ANTISEPTIC HAND SANITIZER- alcohol gel

Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient

Alcohol 72%

Purpose

Antiseptic

Use(s)

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

Inactive ingredients:

Water(Aqua), Glycerin, Butylene Glycol, Aloe Barbadensis Leaf Juice, Carbomer, Aminomethyl Propanol, Isopropyl Myristate, Phenoxyethanol, Ethylhexylglycerin, Fragrance- Lavender.

Questions?

866-961-6181

Package Labeling:

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78229-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.72 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYL GLYCOLATE (UNII: 3H5QAS0HZX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78229-005-00	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/28/2020

Labeler - Beauty Partners LLC (080320170)

Establishment
Name	Address	ID/FEI	Business Operations
Bath Concept Cosmetics (Dongguan) Co., Ltd		529623933	manufacture(78229-005)