DERMADROX- zinc acetate spray

Dermadrox by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active                                 Zinc Acetate 0.45%           

Purpose:

Skin protectant/Astringent

Intended Use:

Rehydrates damaged tissues and protects chaffed,  chapped, cracked, or burned skin.

Warnings:

For External Use Only​Discontinue use if symptoms persist for more than 7 days and consult a physician
Do not use on children under 6 years of age without consulting a physician

​KEEP OUT OF REACH OF CHILDREN

​Avoid contact with eyes​

Directions

Apply generously as often as necessary to minor burns, abraded skin, irritated areas and minor wounds.
Spray directly on the affected area with a thin coat of Dermadrox
Reapply at least every 12 hours. May be used as a wet dressing

Inactive Ingredients

Alcohol, Citric Acid, Corn Syrup, Purified Water, Pyridoxine HCL, Sodium Benzoate, Sodium Chloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMADROX 
zinc acetate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.531 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
WATER (UNII: 059QF0KO0R)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-220-14	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/31/2015

Labeler - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-220)