DERMAMED NATURAL HAND SANITIZER- ethanol gel 
Biological Health Group

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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DM Hand Sanitizer

Ethyl Alcohol 70% v/v

Antimicrobial

Hand sanitizer to help reduce bacteria on the skin that could cause disease
Recommended for repeated use

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Place enough product in your palm to thoroughly cover your hands
Rub hands together briskly until dry
No rinsing required
No towels needed

Water, Aloe Vera Juice, Glycerin, Isopropyl Myristate,Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Aminomethyl Propanol, Propylene Glycol, Fragrance

24010030 ml

DERMAMED NATURAL HAND SANITIZER 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69711-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
WATER (UNII: 059QF0KO0R)  
1,2-PROPANEDITHIOL (UNII: GS64223D79)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69711-800-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2020
2NDC:69711-800-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2020
3NDC:69711-800-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2020
4NDC:69711-800-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2020
5NDC:69711-800-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/28/2020
Labeler - Biological Health Group (079767886)
Establishment
NameAddressID/FEIBusiness Operations
DermaMed Pharmaceutical Inc.202617023manufacture(69711-800)

Revised: 4/2020
Document Id: a4119f89-78c2-0676-e053-2a95a90a04de
Set id: 9fa97dcf-9973-683b-e053-2995a90a6a86
Version: 4
Effective Time: 20200424
 
Biological Health Group