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Baby powder (Powder) Instructions for Use

ATC Code

D08A (Antiseptics and disinfectants)

Active Substance

Zinc oxide (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Drug with astringent and drying action for external use

Pharmacotherapeutic Group

Preparations with emollient and protective action. Zinc preparations

Pharmacological Action

Zinc oxide exerts a drying, adsorbent, astringent, and disinfectant action. It reduces exudation and weeping, which alleviates local manifestations of inflammation and irritation.

Indications

Diaper rash, intertrigo, miliaria, dermatitis, ulcerative skin lesions, superficial wounds and burns.

ICD codes

ICD-10 code Indication
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
L22 Diaper dermatitis
L23 Allergic contact dermatitis
L24 Irritant contact dermatitis
L25 Unspecified contact dermatitis
L30.0 Nummular eczema
L30.4 Erythematous intertrigo
L30.9 Dermatitis, unspecified
L74.3 Unspecified miliaria
L89 Decubitus ulcer and pressure area
L98.4 Chronic skin ulcer, not elsewhere classified
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T30 Burns and corrosions of unspecified body region
ICD-11 code Indication
9A06.70 Atopic eczema of the eyelids
EA40 Tropical phagedenic ulcer
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA82 Nummular dermatitis
EA85.20 Atopic hand eczema
EA85.2Z Hand dermatitis, unspecified
EA85.3 Foot dermatitis
EA89 Generalized eczematous dermatitis of unspecified type
EA8Z Dermatitis or eczema, unspecified
EF60 Ischemic ulceration of the skin
EH40.10 Diaper dermatitis
EH90.Z Pressure ulcer of unspecified degree
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
EK00.Z Allergic contact dermatitis, unspecified
EK02.20 Intertriginous dermatitis due to friction, sweating or contact with body fluids
EK02.Z Irritant contact dermatitis, unspecified
EK5Y Other specified skin lesions provoked by exposure to external factors
EM0Z Unspecified skin disorder
ME60.2 Ulcerative skin lesion of unspecified nature
ND56.0 Superficial injury of unspecified body region
NE11 Burn of unspecified body region

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Apply the preparation externally only. Ensure the skin is clean and dry before application.

For the prevention of diaper rash in infants and children, apply a thin layer to the buttocks, groin, genital area, and skin folds after each diaper change.

For the treatment of diaper dermatitis, miliaria, and intertrigo, apply a thin layer to the affected areas two to three times daily or with every diaper change.

For superficial wounds, burns, and ulcerative skin lesions, apply a thin layer to cover the affected area one to two times daily after cleansing.

For dermatitis and eczema, apply a thin layer to the irritated skin as needed to relieve weeping and inflammation.

Avoid inhalation of powder dust. Do not apply to extensively exuding or heavily bleeding wounds. Discontinue use and consult a physician if irritation occurs or if the condition worsens.

Adverse Reactions

Allergic reactions such as skin itching, hyperemia, skin rash are possible.

Contraindications

Hypersensitivity to zinc oxide.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding if indicated, in the recommended doses.

Pediatric Use

Can be used in children if indicated, in the recommended doses and dosage forms.

Special Precautions

It is not recommended to use zinc oxide preparations in acute purulent-inflammatory diseases.

Avoid contact with the eyes.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Aromasintez, LLC (Russia)

Dosage Form

Bottle OTC Icon Baby powder Powder for topical application: jars or bottles 20 g, 30 g, 40 g or 50 g

Dosage Form, Packaging, and Composition

Powder for topical application white or greyish-white, soft, greasy to the touch; when rubbed between the palms, no grains or lumps should be felt.

100 g
Zinc oxide 10 g

Excipients: potato starch – 10 g, talc – 80 g.

20 g – jars (1) or bottles – cardboard packs.
30 g – jars (1) or bottles – cardboard packs.
40 g – jars (1) or bottles – cardboard packs.
50 g – jars (1) or bottles – cardboard packs.

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Bottle OTC Icon Baby powder Powder for topical application: sachets 2 g or 5 g 3, 5, 10, 20 or 30 pcs., jars 40 g or 50 g 1 pc.

Dosage Form, Packaging, and Composition

Powder for topical application white or greyish-white in color, soft, greasy to the touch; when rubbed between the palms, no grains or lumps should be felt.

100 g
Zinc oxide 10 g

Excipients: potato starch – 10 g, talc – 80 g.

2 g – heat-sealed sachets (3) – cardboard packs.
2 g – heat-sealed sachets (5) – cardboard packs.
2 g – heat-sealed sachets (10) – cardboard packs.
2 g – heat-sealed sachets (20) – cardboard packs.
2 g – heat-sealed sachets (30) – cardboard packs.
5 g – heat-sealed sachets (3) – cardboard packs.
5 g – heat-sealed sachets (5) – cardboard packs.
5 g – heat-sealed sachets (10) – cardboard packs.
5 g – heat-sealed sachets (20) – cardboard packs.
5 g – heat-sealed sachets (30) – cardboard packs.
40 g – polymer jars (1) – cardboard packs.
50 g – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle OTC Icon Baby powder Powder for topical application: jars 40 g or 50 g

Dosage Form, Packaging, and Composition

Powder for topical application white or greyish-white in color, soft, greasy to the touch; when rubbed between the palms, no grains or lumps should be felt.

100 g
Zinc oxide 10 g

Excipients: potato starch, talc.

40 g – polyethylene jars.
50 g – polyethylene jars.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle OTC Icon Baby powder Powder for topical application 80 g+10 g+10 g/100 g: jar 50 g

Dosage Form, Packaging, and Composition

Powder for topical application white or greyish-white in color, soft, greasy to the touch; when rubbed between the palms, no grains or lumps should be felt.

100 g
Talc 80 g
Zinc oxide 10 g
Potato starch 10 g

40 g – polyethylene jars.

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