DEFENSE AG HAND SANITIZER- ipa hand sanitizer gel 
Nexderma

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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IPA Hand Sanitizer DAG-revised

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Antiseptic to help reduce bacteria that potentially can cause disease

Inactive ingredients

Ultra Pure Water, Hydroxyethyl Cellulose, Curcumin

Purpose

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

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are unavailable.

Warnings

Keep away form fire and flame.
Flammable
For external use on hands only.
Keep out of eye, 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 15-30 (58-86F)
Avoid freezing and excessive heat above 40C (104F)
Will damage wood finishes, plastics and some fabrics.

Do not use

Adult supervision recommended for children under 6 years old.

Directions

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

Administration: Topical

Other information

Package Label - Principal Display Panel

8 oz label4 oz label16 oz label1 Gal label

DEFENSE AG HAND SANITIZER 
ipa hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79930-7105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 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
Coloryellow (light translucent yellow hint) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79930-7105-1100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
2NDC:79930-7105-2250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
3NDC:79930-7105-3350 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
4NDC:79930-7105-4500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/30/2020
5NDC:79930-7105-53785 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 finalpart333A09/25/2020
Labeler - Nexderma (079533940)
Establishment
NameAddressID/FEIBusiness Operations
Nexderma079533940manufacture(79930-7105) , pack(79930-7105) , label(79930-7105)

Revised: 9/2020
Document Id: b0255011-29c4-96c2-e053-2a95a90ac7e9
Set id: afeaa191-4138-4fde-e053-2a95a90a7690
Version: 2
Effective Time: 20200925
 
Nexderma