Country: United States
Language: English
Source: NLM (National Library of Medicine)
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)
Naterra International INC.
Zinc Oxide
Zinc Oxide 23.8 g in 85 g
TOPICAL
OTC DRUG
Uses: Helps treat and prevent diaper rash , chaged skin and minor skin irritation by protecting and ealing out wetness. Direction Change wet and soiled diapers promptly; cleanse diaper area and allow to dry Apply product liberally with each diaper change and expecially at bedtime when exposure to wet diapers may be prolonged
OTC monograph not final
BABY MAGIC DIAPER RX - ZINC OXIDE CREAM NATERRA INTERNATIONAL 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._ ---------- Active Ingredient : Zinc Oxide (28%) Uses: Helps treat and prevent diaper rash , chaged skin and minor skin irritation by protecting and ealing out wetness. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or cntact a Poison Control Center right away Warnings; For external use only Direction Change wet and soiled diapers promptly; cleanse diaper area and allow to dry Apply product liberally with each diaper change and expecially at bedtime when exposure to wet diapers may be prolonged Allantoin ,Ascorbyl Palmitate , Beeswax , BHA , Carthamus Tintorius (Safflower) Seed Oil , Fragrance , Glycyrrhiza Glabra (Licorice) Root Extract , Persea Gratissima (Avocado) Oil , Petrolatum , Retinyl Palmitate , Tocopherol , Tocopheryl Acetate. Enter section text here BABY MAGIC DIAPER RX zinc oxide cream Naterra International INC. PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:4576 5-5130 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 23.8 g in 8 5 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH ALLA NTO IN (UNII: 344S277G0 Z) ASCO RBYL PA LMITA TE (UNII: QN8 3US2B0 N) YELLO W WAX (UNII: 2ZA36 H0 S2V) BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U) SAFFLO WER O IL (UNII: 6 5UEH26 2IS) GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H) AVO CADO O IL (UNII: 6 VNO72PFC1) PETRO LA TUM (UNII: 4T6 H12BN9 U) VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC) TO CO PHERO L (UNII: R0 ZB2556 P8 ) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:4576 5-5130 -0 8 5 g in 1 TUBE MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUM Read the complete document