Label: DIPHENHYDRAMINE - diphenhydramine hydrochloride, zinc acetate cream
- NDC Code(s): 54868-0113-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5354
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated June 5, 2012
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- Active ingredient
Diphenhydramine hydrochloride 2%
Zinc acetate 0.1%Close
- temporarily relieves pain and itching associated with:
- insect bites
- minor burns
- minor skin irritations
- minor cuts
- rashes due to poison ivy, poison oak and poison sumac
- dries the oozing and weeping of poison ivy, poison oak and poison sumac
For external use only
Do not use
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
Stop use and ask a doctor if
- condition worsens or does not improve within 7 days
- symptoms persist for 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 or contact a Poison Control Center right away.
- do not use more than directed
- adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
- Other information
- store at 20°-25°C (68°-77°F)
- Inactive ingredients
cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified waterClose
- Questions or comments?
- Principal Display Panel
Diphenhydramine Hydrochloride 2%
Topical Analgesic/Skin Protectant
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
- INGREDIENTS AND APPEARANCE
diphenhydramine hydrochloride, zinc acetate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-0113(NDC:0904-5354) 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 - UNII:J41CSQ7QDS) ZINC ACETATE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-2 STEARATE (UNII: 94YQ11Y95F) 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:54868-0113-0 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/23/2008 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel