DERMAMINE EXTRA STRENGTH ITCH STOPPING- diphenhydramine and zinc acetate cream

Dermamine by

Drug Labeling and Warnings

Dermamine by is a Otc medication manufactured, distributed, or labeled by Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

• Temporarily relieves pain and itching associated with:
  • insect bites
  • minor burns
  • sunburn
  • scrapes
  • 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

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

• do not use more than directed
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other information

• store between 15° and 30° C (59° and 86° F)
• close cap tightly after use
• do not use if seal on tube is punctured or missing

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)

INGREDIENTS AND APPEARANCE

DERMAMINE   EXTRA STRENGTH ITCH STOPPING
diphenhydramine and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE	0.02 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.001 U  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-023-01	1 in 1 BOX	03/01/2014
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 NOT FINAL	part348	03/01/2014

Labeler - Natureplex LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-023)