NDC | 0168-0062-02, 0168-0062-16, 0168-0062-31 |
Set ID | ee65a059-7df4-4d5e-a70e-14861764597e |
Category | HUMAN OTC DRUG LABEL |
Packager | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- Active Ingredient:
- Purpose:
- INDICATIONS & USAGE
- WARNINGS
- Keep out of reach of children.
-
DOSAGE & ADMINISTRATION
Directions:
- For diaper rash:
- change wet and soiled diapers promptly, allow to dry
- apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. To dry the oozing and weeping of poison ivy, poison oak or poison sumac:
- apply ointment liberally as often as needed
- SPL UNCLASSIFIED SECTION
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
-
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
NDC 0168-0062-31
Fougera®
Zinc Oxide Ointment USP
Skin Protectant
To reliably help soothe and protect chafed skin.
INDICATION: Helps and prevent diaper rash. Protects chafed skin due to diaper rash and helps protect from wetness. Dries the oozing and weeping of poison ivy, poison oak and poison sumac.
NET WT 28.35g (1 Oz)
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
-
INGREDIENTS AND APPEARANCE
ZINC OXIDE
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0062 Route of Administration TOPICAL Active Ingredient/Active Moiety 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 MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) WHITE WAX (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0168-0062-31 1 in 1 CARTON 1 28.35 g in 1 TUBE 2 NDC:0168-0062-02 1 in 1 CARTON 2 56.70 g in 1 TUBE 3 NDC:0168-0062-16 453.6 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/01/1968 Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)