Label: DERMAGESIC- pramoxine hcl, zinc oxide, calamine cream
- NDC Code(s): 54859-202-04
- Packager: Llorens Pharmaceutical International Division
- 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.
Drug Label Information
Updated December 23, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
Warnings
For external use only. Avoid contact with the eyes
- Not for Pediatric use
- Hypersensitivity to "caine" anesthetics
Do not use
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth.
Ask a doctor before use
- on chicken pox
- on measles
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
- Directions
- Inactive Ingredients
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMAGESIC
pramoxine hcl, zinc oxide, calamine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 4 mg in 1 g FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 4 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARETH-6 (UNII: 2RJS3559D3) CETEARETH-25 (UNII: 8FA93U5T67) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-202-04 113 g in 1 JAR; Type 0: Not a Combination Product 04/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part347 04/01/2016 Labeler - Llorens Pharmaceutical International Division (037342305)