AMOUAGE- sanitizer gel gel

AMOUAGE by

Drug Labeling and Warnings

AMOUAGE by is a Otc medication manufactured, distributed, or labeled by AMOUAGE SAOC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

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

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

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry
• Supervise children under 6 years of age when using this product to avoid swallowing.

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

INGREDIENTS AND APPEARANCE

AMOUAGE 
sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79809-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79809-111-11	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/17/2020
2	NDC: 79809-111-12	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/17/2020
3	NDC: 79809-111-13	120 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	09/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/17/2020

Labeler - AMOUAGE SAOC (557929992)

Establishment
Name	Address	ID/FEI	Business Operations
AMOUAGE SAOC		557929992	manufacture(79809-111)