Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Trifecta Pharmaceuticals USA
TOPICAL
OTC DRUG
Skin Protectant - Protects skin - Protects and releives chafed skin due to diaper rash - helps seal out wetness - Dries the oozing and weeping of poison ivy, oak and sumac
OTC monograph final
ZINC OXIDE 20%- ZINC OXIDE OINTMENT TRIFECTA PHARMACEUTICALS USA _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._ ---------- ZINC OXIDE OINTMENT 20% DRUG FACTS ACTIVE INGREDIENT Zinc Oxide 20% PURPOSE Skin Protectant USES Protects skin Protects and releives chafed skin due to diaper rash - helps seal out wetness Dries the oozing and weeping of poison ivy, oak and sumac KEEP OUT OF THE REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center immediately. WARNINGS FOR EXTERNAL USE ONLY When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition. DIRECTIONS Apply ointment liberally as often as necessary For the treatment of diaper rash, change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged OTHER INFORMATION Store at controlled room temperature 15° - 30°C (59° - 86°F) INACTIVE INGREDIENTS Mineral Oil, Petrolatum DISTRIBUTED BY: Trifecta Pharmaceuticals USA, LLC. 101 NE Third Avenue, Ste. 1500 Ft. Lauderdale, FL. 33301, USA. Product of PRC www.trifecta-pharma.com ZINC OXIDE 20% zinc oxide ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:69396-021 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.2 g in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:69396-021- 02 1 in 1 BOX 01/26/2018 1 60 g in 1 TUBE; Type 0: Not a Combination Product Trifecta Pharmaceuticals USA MARKETING INFORM Baca dokumen lengkap