מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
C.B. Fleet Company, Inc.
TOPICAL
OTC DRUG
- Helps treat and prevent diaper rash - Protests chafed skin due to diapter rash and helps seal out wetness
OTC monograph final
BOUDREAUXS- ZINC OXIDE CREAM C.B. FLEET COMPANY, INC. _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._ ---------- DRUG FACTS ACTIVE INGREDIENT Zinc Oxide, 16%, Skin Protectant US ES Helps treat and prevent diaper rash Protests chafed skin due to diapter rash and helps seal out 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 after 7 days KEEP OUT OF REACH OF CHILDREN to prevent accidental ingestion If swallowed, seek medical help or call Poison Control Center immediately DIRECTIONS FOR USE Change wet and soiled diapers immediately Cleanse the diaper area and allow to dry Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime OTHER INFORMATION Store at room temperature, 15C to 30C (59F to 86F) Remove foil seal from the tube's tip or from jar Use with infants, children and adults Will stain clothing and fabric INACTIVE INGREDIENTS Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, White Petrolatum QUESTIONS OR COMMENTS Phone 1-855-785-2888 website www.buttpaste.com BOUDREAUXS zinc oxide cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:0 132-0 333 ROUTE OF ADMINISTRATION TOPICAL C.B. Fleet Company, Inc. ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 16 g in 113 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH CASTO R O IL (UNII: D5340 Y2I9 G) MINERAL O IL (UNII: T5L8 T28 FGP) PARAFFIN (UNII: I9 O0 E3H2ZE) BALSAM PERU (UNII: 8 P5F8 8 1OCY) PETRO LATUM (UNII: 4T6 H12BN9 U) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:0 132-0 333-44 113 g in 1 TUBE; Type 0 : No t a Co mb קרא את המסמך השלם