NDC | 11527-069-04 |
Set ID | 77f0593e-f694-4c02-9fd9-ad56ff2a920c |
Category | HUMAN OTC DRUG LABEL |
Packager | Sheffield Pharmaceuticals LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- Drug Facts:
- Active ingredients
- Purpose
- Uses
-
Warnings
For external use only
Do not use
- on large areas of the body
- with any other product containing diphenhydramine , even one taken by the mouth.
Ask a Doctor before use
- on chicken pox
- on measles
When using this product avoid contact with eyes.
Stop use and ask a doctor if
- conditions worsen or does not improve within 7 days
- symptoms persist for more than 7 days or clear up and occur agian within a few days
- Keep this and all drugs out of the reach of children.
- Directions
- Inactive ingredients
- Principal Display Panel 1.25 oz Carton
- Principal Display Panel 1.25 oz Tube
-
INGREDIENTS AND APPEARANCE
DR. SHEFFIELD ANTI ITCH CREAM
anti itch cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-069 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 20 mg in 1 g ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 mg in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-20 STEARATE (UNII: NBX892EA57) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11527-069-04 1 in 1 CARTON 11/11/2008 1 35 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 final part347 11/11/2008 Labeler - Sheffield Pharmaceuticals LLC (151177797) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(11527-069)