DERMADROX- zinc acetate spray 
Geritrex 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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Dermadrox Spray

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

image description

DERMADROX 
zinc acetate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.531 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-220-14118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/31/2015
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex LLC112796248manufacture(54162-220)

Revised: 7/2015
Document Id: f4238cc8-536d-4900-ae6e-ddb3b3cc9fbb
Set id: 87dc161d-aaef-4ff3-8d26-a301ea9cd6c5
Version: 1
Effective Time: 20150731
 
Geritrex LLC