B PURE HAND SANITIZER SHEA BUTTER SCENTED- alcohol liquid

b pure Hand Sanitizer Shea Butter Scented by

Drug Labeling and Warnings

b pure Hand Sanitizer Shea Butter Scented by is a Otc medication manufactured, distributed, or labeled by FOURSTAR GROUP USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol, 70% v/v

Purpose

Antimicrobial

Uses

hand sanitizer to help reduce bacteria on skin

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation, excessive redness or rash develops.

Keep out of reach of children. 

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Put a dime sized drop onto hands and rub together briskly until dry.

Other information

Store below 110°F (43°C)

Inactive ingredients

water, glycerin, propylene glycol, acrylates/c10-30 alkyl acrylate crosspolymer, fragrance, aminomethyl propanol

Package Labeling:

INGREDIENTS AND APPEARANCE

B PURE HAND SANITIZER SHEA BUTTER SCENTED 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-116-00	1 in 1 BOX	08/25/2024
1		89 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/25/2024

Labeler - FOURSTAR GROUP USA, INC. (140099503)