NDC | 69571-005-01, 69571-005-02 |
Set ID | fde2069b-344e-46da-bb95-c5113e0f35d6 |
Category | HUMAN OTC DRUG LABEL |
Packager | FRONT PHARMACEUTICAL PLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For external use only.
Do not use
- over large areas of the body
- with any other product containing diphenhydramine including those taken orally
When using this product •avoid contact with eyes
Ask a doctor before use
•on chicken pox •on measles
Stop use and ask a doctor if
- symptoms last for more than 7 days
- the condition gets worse
- symptoms clear up and then occur again within a few days
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- label
-
INGREDIENTS AND APPEARANCE
FAMILY WELLNESS
diphenhydramine hydrochloride, zinc acetate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69571-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 2 g in 100 g ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) LAURETH-23 (UNII: N72LMW566G) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69571-005-02 1 in 1 BOX 03/29/2017 1 NDC:69571-005-01 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/29/2017 Labeler - FRONT PHARMACEUTICAL PLC (530897792) Establishment Name Address ID/FEI Business Operations FRONT PHARMACEUTICAL PLC 530897792 manufacture(69571-005)