HAND SANITIZER WITH VITAMIN E- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by BBC GROUP LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Alcohol Denat. 62%

Purpose

Antiseptic

Uses

■ to decrease bacteria on the skin that could cause disease ■ recommended for repeated use

Warnings

For external use only. Flammable, keep away from fire or flame

When using this product

■ keep out of eyes. In case of contact with eyes, flush thoroughly with water. ■ avoid contact with broken skin ■ do not inhale or ingest

Stop use and ask a doctor if

■ irritation and redness develop ■ condition persists for more than 72 hours

Keep out of reach of children

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

Directions

■ wet hands thoroughly with product and allow to dry without wiping ■ for children under 6, use only under adult supervision ■ not recommended for infants

Other information

■ do not store above 105ºF ■ may discolor some fabrics ■ harmful to wood finishes and plastics

Inactive ingredients

Water, PEG-40 Hydrogenated Castor Oil, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Denatonium Benzoate, Tocopheryl Acetate

Questions?

1-888-287-1915

Package Label

INGREDIENTS AND APPEARANCE

HAND SANITIZER  WITH VITAMIN E
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76383-014
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
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76383-014-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
2	NDC: 76383-014-03	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
3	NDC: 76383-014-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
4	NDC: 76383-014-12	354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/11/2020
5	NDC: 76383-014-30	887 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/11/2020
6	NDC: 76383-014-34	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/11/2020
7	NDC: 76383-014-28	3789 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2020
8	NDC: 76383-014-02	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2020
9	NDC: 76383-014-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2020
10	NDC: 76383-014-50	50 in 1 BOX	09/07/2020
10	NDC: 76383-014-07	2 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/11/2020

Labeler - BBC GROUP LIMITED (421270060)

Establishment
Name	Address	ID/FEI	Business Operations
BBC GROUP LIMITED		421270060	manufacture(76383-014)