DEFENSE AG- defense ag sanitizing gel gel 
Nexderma 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(s)

Alcohol 80% - Antiseptic to help reduce bacteria that potentially can cause disease

Hydroxyethyl Cellulose

Curcumin

Ultra Pure Water

Use

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.

Warnings

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 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

Do not use

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.

Adminstration: Topical

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

Package Label - Principal Display Panel

000 mL NDC: 00000-000-00 4oz label 8oz label12 oz label16oz label

DEFENSE AG 
defense ag sanitizing gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79930-7102
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
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 0.2 mL  in 100 mL
CURCUMIN (UNII: IT942ZTH98) 1.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79930-7102-1100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
2NDC:79930-7102-2250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
3NDC:79930-7102-4500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
4NDC:79930-7102-3350 mL in 1 BOTTLE, DISPENSING; 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 - Nexderma Inc (079533940)
Establishment
NameAddressID/FEIBusiness Operations
Nexderma079533940manufacture(79930-7102) , pack(79930-7102) , label(79930-7102)

Revised: 9/2020
Document Id: ab3553b2-3966-4ced-e053-2a95a90a4176
Set id: ae6b0c06-9ef4-7e1e-e053-2995a90a9ebb
Version: 1
Effective Time: 20200930
 
Nexderma Inc