MY FAIR BABY DIAPER RASH- zinc oxide cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Anicare Pharmaceuticals Pvt. Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin Protection - Helps treat and prevent diaper rash - Soothes and relieves irritated skin - Protects your baby's skin from wetness Condition worsens or does not improve within 7 days or symptoms clear up and occur again within a few days.
Authorization status:
OTC monograph final
Authorization number:
47046-179-01, 47046-179-02

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MY FAIR BABY DIAPER RASH- zinc oxide cream

Anicare Pharmaceuticals Pvt. Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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diaper rash cream

Active Ingredient

Zinc Oxide 13%

Purpose

Skin Protection

Use

Helps treat and prevent diaper rash

Soothes and relieves irritated skin

Protects your baby's skin from wetness

Warnings

For external use only

When using this product

Avoid contact with the eyes

Stop use and ask a doctor if

Condition worsens or does not improve within 7 days or symptoms clear up and occur again within a

few days.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Change wet and soiled diapers promptly

Cleanse the diaper area

Allow to dry

Ointment should be applied at every diaper change, specially at bedtime or anytime when exposure

to wet diapers may be prolonged

Other Information

Store at 20º to 25°C (68° to 77°F)

Inactive Ingredients

Water, Mineral Oil, Petrolatum, Cetyl Alcohol, Ceteareth-25, Glyceryl Monostearate, Beeswax,

Microcrystaline Wax, Fragrance, Dimethicone, Aloe Barbadensis Leaf Extract (Aloe Vera),

Tocopheryl Acetate, Methylparaben, Propylparaben, Methylchloroisothiazolinone,

Methylisothiazolinone, Carbomer

Carton Label

MY FAIR BABY DIAPER RASH

zinc oxide cream

Anicare Pharmaceuticals Pvt. Ltd.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:470 46 -179

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

13 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

MINERAL O IL (UNII: T5L8 T28 FGP)

PETRO LATUM (UNII: 4T6 H12BN9 U)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CETEARETH-2 5 (UNII: 8 FA9 3U5T6 7)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

WHITE WAX (UNII: 7G1J5DA9 7F)

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:470 46 -179 -0 2

1 in 1 CARTON

0 8 /30 /20 11

1

NDC:470 46 -179 -0 1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 8 /30 /20 11

Labeler -

Anicare Pharmaceuticals Pvt. Ltd. (916837425)

Revised: 12/2020

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