AMBROSIA FRAGRANCE SANITIZER- alcohol solution 
Ambrosia Frangrance

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% 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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

236ml label

Package Label - Principal Display Panel

176ml label

AMBROSIA FRAGRANCE SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74491-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 L  in 100 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L  in 100 L
WATER (UNII: 059QF0KO0R) 18.425 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74491-0001-1.236 L in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
2NDC:74491-0001-2.176 L in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2020
Labeler - Ambrosia Frangrance (053734159)
Establishment
NameAddressID/FEIBusiness Operations
Ambrosia Fragrance053734159manufacture(74491-0001)

Revised: 4/2020
Document Id: d87fbdef-e1ce-4865-b27d-ab05abdc870b
Set id: 6d5a4fd1-b29d-4a93-af7c-fcddaf3561a4
Version: 7
Effective Time: 20200421
 
Ambrosia Frangrance