DERMAMINE  EXTRA STRENGTH ITCH STOPPING- diphenhydramine and zinc acetate cream 
Natureplex LLC

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.

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Dermamine
Extra Strength Itch Stopping Cream

Drug Facts

Active ingredientsPurposes
Diphenhydramine Hydrochloride 2%Topical Analgesic
Zinc Acetate 0.1%Skin Protectant

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 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

  • 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 the reach of children. In case of accidental ingestion, seek medical attention right away or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

DMDM Hydantoin, GMS, isopropyl myristate, light mineral oil, methylparaben, propylparaben, ritacol, purified water

Questions or comments?

1-866-323-0107

PRINCIPAL DISPLAY PANEL - 35 g Tube Box

EXTRA STRENGTH

BLOCKS
THE ITCH-CAUSING
HISTAMINES

Natureplex

Dermamine
Itch Stopping
Cream
Topical Analgesic Skin Protectant

NDC 67234-023-01

NET WT. 1.25 Oz.(35g)

Principal Display Panel - 35 g Tube Box
DERMAMINE   EXTRA STRENGTH ITCH STOPPING
diphenhydramine and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE0.02 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.001 U  in 1 g
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-023-011 in 1 BOX03/01/2014
135 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/01/2014
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-023)

Revised: 10/2017
Document Id: 8a8a28e4-f72c-41e2-b190-3ca26b7c89c4
Set id: ede192d1-5a2d-472c-8bd2-3966b26cb8f5
Version: 2
Effective Time: 20171020
 
Natureplex LLC