Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Advanced Generic Corporation
TOPICAL
OTC DRUG
Skin protectant - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness
OTC monograph final
BIODCREAM- ZINC OXIDE CREAM ADVANCED GENERIC CORPORATION _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._ ---------- ACTIVE INGREDIENT Zinc Oxide 15.25% PURPOS E Skin protectant US ES helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness WARNINGS For external use only. When using this product avoid contact with eyes. Stop use and ask doctor if condition worsens or lasts more than 7 days Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately. DIRECTIONS Change wet or soiled diaper promptly Cleanse the diaper area and allow to dry Apply Cream liberally as often as necessary, with each diaper change, especially at bedtime or when exposure to wet diapers may be prolonged. INACTIVE INGREDIENTS beeswax, butylated hydroxyl anisole, diazolidinyl urea, lanolin oil, lavender fragrance, methylparaben, paraffinum liquidum, propylene glycol, propylparaben, white petrolatum. QUESTIONS OR COMMENTS: 1-305-403-3788 BIODCREAM zinc oxide cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:45737-70 1 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37) ZINC CATION 15.25 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH YELLO W WAX (UNII: 2ZA36 H0 S2V) MINERAL O IL (UNII: T5L8 T28 FGP) BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U) PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3) DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8 C7HI9 T) PRO PYLPARABEN (UNII: Z8 IX2SC1OH) LANO LIN O IL (UNII: OVV5IIJ58 F) PETRO LATUM (UNII: 4T6 H12BN9 U) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:45737-70 1-0 4 125 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct 0 4/0 1/20 16 MARKETI Прочетете целия документ