HAND SANITIZER- alcohol gel 
Bath Concept Cosmetics (Dongguan) Co., Ltd

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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Hand Sanitizer

Drug Facts

Active Ingredient

Alcohol 62%

Purpose

Antiseptic

Uses

  • For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

  • Flammable, keep away from fire and flame.
  • Does not contain grain alcohol; do not drink, if taken internally serious gastric disturbances will result.

When using this product

  • Avoid the eyes and mucous membranes
  • In the case of eyes or mucous membranes contact, rinse area thoroughly with water
  • In case of deep or puncture wounds or serious burns, consult physician.
  • If redness, irritation, swelling or pain persists or increases or if infection occurs discontinue use and consult physician.

  • If swallowed, contact a doctor or Poison Control Center immediately.

In case of irritation, discontinue use and consult your doctor.

Directions:

  • Rub dime sized amount between hands until dry.
  • Supervise children in the use of this product.
  • In the case of eye contact, rinse eyes thoroughly with water.

Other Information:

Store below 106ºF (41 ºC). May discolor certain fabrics or surfaces.

Inactive Ingredients

Aminomethyl Propanol, Carbomer, Water.

​Questions?

  • 1-800-369-4670

Package Labeling:

Label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61805-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61805-110-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/10/2020
Labeler - Bath Concept Cosmetics (Dongguan) Co., Ltd (529623933)

Revised: 4/2020
Document Id: a2a0894e-11ab-7371-e053-2a95a90a79bb
Set id: 065e083f-3c13-495d-8619-df45c5fce68b
Version: 2
Effective Time: 20200406
 
Bath Concept Cosmetics (Dongguan) Co., Ltd