País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Anicare Pharmaceuticals Pvt. Ltd.
TOPICAL
OTC DRUG
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.
OTC monograph final
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._ ---------- 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) Leia o documento completo