DEFEND HAND SANITIZER- ethyl alcohol gel 
Adonis, 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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Defend- Gel Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70% v/v. .......... Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on hands.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product avoid contact with eyes. If contact occurs, rinse rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness devleops and lasts.

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

Directions

Other information

Inactive ingredients

glycerin, purified water ,Aloe Barbadensis, Alkyl Acrylates Crosspolymer ,Aminomethyl Propanol

Package Label - Principal Display Panel

Defend

DEFEND  HAND SANITIZER
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77356-999
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
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77356-999-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/2020
Labeler - Adonis, LLC. (116983147)
Registrant - Adonis, LLC. (116983147)
Establishment
NameAddressID/FEIBusiness Operations
Adonis, LLC.116983147manufacture(77356-999)

Revised: 7/2020
Document Id: aa6b19fc-3d66-4804-e053-2a95a90abe5e
Set id: a0d2a2a5-038d-45b1-9f5c-528cf1c9bbe9
Version: 3
Effective Time: 20200714
 
Adonis, LLC.