Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
SOLA Pharmaceuticals
TOPICAL
OTC DRUG
Skin protectant Skin Protectant - Helps treat and prevent diaper rash - Dries the ozzing and weeping of poison: •Ivy •Oak •Sumac
OTC monograph final
ZINC OXIDE 20%- ZINC OXIDE 20% OINTMENT SOLA PHARMACEUTICALS _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 20% OINTMENT _ACTIVE INGREDIENT_ Zinc Oxide 20% _PURPOSE_ Skin protectant _USES_ Skin Protectant Helps treat and prevent diaper rash Dries the ozzing and weeping of poison: •Ivy •Oak •Sumac _WARNINGS_ FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT avoid contact with eyes STOP USE AND ASK A DOCTOR IF condition worsens symptoms last more than 7 days or clear up and occur again within a few days _KEEP OUT OF REACH OF CHILDREN. _If swallowed, get medical help _DIRECTIONS_ FOR DIAPER RASH: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply paste liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged FOR POISON IVY, OAK, AND SUMAC: Apply as needed _OTHER INFORMATION_ Store at room temperature Avoid excessive heat and humidity _INACTIVE INGREDIENTS_ Cetomacrogol 1000, Cetostearyl alcohol, Mineral oil, Petrolatum QUESTIONS OF COMMENTS? Call 1-866-747-7365 Manufactured for : SOLA Pharmaceuticals Baton Rouge, LA 70810 Store at room temperature. Avoid excessive heat and humidity. Zinc Oxide 20% Ointment NDC 70512-103-30 Qty: 28.4g ZINC OXIDE 20% zinc oxide 20% ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:70512-103 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY SOLA Pharmaceuticals INGREDIENT NAME BASIS OF STRENGTH STRENGTH ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CETETH-20 (UNII: I835H2IHHX) PETROLATUM (UNII: 4T6H12BN9U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MINERAL OIL (UNII: T5L8T28FGP) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 Lire le document complet