AIROME HAND SANITIZER BERGAMOT LIME- alcohol gel 
B&B Acquisition, Inc.

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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Airome Hand Sanitizer Bergamot Lime

Drug Facts

Active Ingredient

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

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

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

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.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Ammonium Acryloyldimethyltaurate/VP Copolymer, Citrus SInensis Peel Oil Expressed, CItrus Aurantium Bergamia (Bergamot) Peel Oil, Citrus Aurantifolia (Lime) Oil, Aloe Barbadensis Leaf Juice, Niacinamide, Hydrogen Peroxide, Maltodextrin, Tocopheryl Acetate, DL-Panthenol

Package Labeling:

Label

AIROME HAND SANITIZER BERGAMOT LIME 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80197-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)  
WATER (UNII: 059QF0KO0R)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
LIME OIL (UNII: UZH29XGA8G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80197-000-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product08/22/202010/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/22/202010/01/2021
Labeler - B&B Acquisition, Inc. (080886206)
Establishment
NameAddressID/FEIBusiness Operations
B&B Acquisition, Inc.080886206repack(80197-000)

Revised: 10/2021
 
B&B Acquisition, Inc.