AMOUAGE- sanitizer gel gel 
AMOUAGE SAOC

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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AMOUAGE Sanitizer Gel

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

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

May discolor certain fabrics or surfaces

Inactive ingredients

alpha-isomethyl ionone, carbopol aqua sf-1, citronellol, eugenol, geraniol, glycerin, hydroxycitronellal, rose (as parfum), sodium hydroxide, purified water

Package Label - Principal Display Panel

60 mL NDC:79809-111-11

60 mL NDC:79809-111-11

AMOUAGE 
sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79809-111
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
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
ROSE OIL (UNII: WUB68Y35M7)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
GERANIOL (UNII: L837108USY)  
EUGENOL (UNII: 3T8H1794QW)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79809-111-1160 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
2NDC:79809-111-12300 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
3NDC:79809-111-13120 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product09/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/17/2020
Labeler - AMOUAGE SAOC (557929992)
Establishment
NameAddressID/FEIBusiness Operations
AMOUAGE SAOC557929992manufacture(79809-111)

Revised: 11/2021
Document Id: d06fc376-3f2f-b30e-e053-2a95a90a414a
Set id: af8750ca-a9c9-5d0f-e053-2995a90a5a7d
Version: 2
Effective Time: 20211110
 
AMOUAGE SAOC