AMBRE HAND SANITIZER- alcohol liquid 
Ambre Blends

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 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

Inactive ingredients

Purified water USP, glycerine, Hydroxypropyl Cellulose, Vitamin E, Cocos Nucifera oil, and Ahnu Essence Natural Fragrance

Package Label - Principal Display Panel

29.57 mL NDC: 81060-002-01 Label

AMBRE HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81060-002
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
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81060-002-0129.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/18/2020
Labeler - Ambre Blends (021756131)
Registrant - Ambre Blends (021756131)
Establishment
NameAddressID/FEIBusiness Operations
Ambre Blends021756131manufacture(81060-002)

Revised: 1/2022
Document Id: d5f59f66-38fd-b1d8-e053-2a95a90a9fd1
Set id: b479f016-dc4e-7084-e053-2a95a90a0807
Version: 6
Effective Time: 20220119
 
Ambre Blends