HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Bath Concept Cosmetics (Dongguan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 62%

Purpose

Antiseptic

Use

■ For handwashing to decrease bacteria on the skin ■ Recommended for repeated use

Warnings

■ For external use only

■ Flammable, keep away from fire & flame

■ Does not contain grain alcohol;do not drink. If taken internally will produce serious gastric disturbances

When using this product

■ Avoid the eyes and mucous membranes

■ In the case of eyes or mucous membranes contact, rinse area thoroughly with water

Stop use and ask a doctor if

■ Condition worsens

■ Redness or irritation develops

■ If condition persists for more than 3 days

Keep out of reach of children

■ If swallowed contact a doctor or Poison Control Center immediately.

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 105°F ■ May discolor some fabrics

Inactive Ingredients

Water, Glycerin, Fragrance, Carbomer, Aminomethyl Propanol, Denatonium Benzoate, Mica, Yellow 5

Questions?

■ 1-800-278-9218

Package Label Gold

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61805-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61805-401-30	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Bath Concept Cosmetics (Dongguan) Co., Ltd (529623933)

Establishment
Name	Address	ID/FEI	Business Operations
Bath Concept Cosmetics (Dongguan) Co., Ltd		529623933	manufacture(61805-401)