DEFENSE AG- defense ag hand sanitizing gel gel 
Nederma Inc

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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Active Ingredient

Ethyl Alcohol 80% - Antiseptic to help reduce bacteria that potentialy can cause disease.

Inactive Ingredients

Glycerol

Carbomer

Ultra Pure Water

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Apply Defense Ag on hands rubbing together until dried. Repeat as often as necessary.

Adult super vision recommended for children under 6 years old.

Keep away from fire and flame.

Flammable.

For external use on hands only.

Keep out of eyes, ears and mouth.

If contact in eyes, flush thoroughly with water.

Keep out of reach of children.

If swallowed seek medical help immediately or call your poison control center.

Store between 15-30C (58-86F).

Avoid freezing and excessive heat above 40C( 104F).

will damage wood finishes, plastics and some fabrics.

Children less than 2 months of age or on open wounds.

Dosage: upto 10 times a day

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Administration: Topical

Purpose: To help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Nexderma Defense Ag

4oz label 16oz label

DEFENSE AG 
defense ag hand sanitizing gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79930-7101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E) 0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 10 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79930-7101-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
2NDC:79930-7101-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/30/2020
Labeler - Nederma Inc (079533940)

Revised: 7/2020
Document Id: aaf48a00-c5d9-2f55-e053-2a95a90aaf3d
Set id: aaf48a00-c5d8-2f55-e053-2a95a90aaf3d
Version: 1
Effective Time: 20200721
 
Nederma Inc