HAND SANITIZER WITH VITAMIN E- alcohol liquid 
BBC GROUP LIMITED

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 with VitE

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

package label

HAND SANITIZER  WITH VITAMIN E
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76383-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76383-014-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/11/2020
2NDC:76383-014-0389 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/11/2020
3NDC:76383-014-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/11/2020
4NDC:76383-014-12354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/11/2020
5NDC:76383-014-30887 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/11/2020
6NDC:76383-014-341000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/11/2020
7NDC:76383-014-283789 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/29/2020
8NDC:76383-014-0230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/29/2020
9NDC:76383-014-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/29/2020
10NDC:76383-014-5050 in 1 BOX09/07/2020
10NDC:76383-014-072 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/11/2020
Labeler - BBC GROUP LIMITED (421270060)
Establishment
NameAddressID/FEIBusiness Operations
BBC GROUP LIMITED421270060manufacture(76383-014)

Revised: 9/2020
Document Id: af10299d-c9aa-7726-e053-2995a90a8163
Set id: a7945852-99c4-1287-e053-2a95a90a7914
Version: 4
Effective Time: 20200911
 
BBC GROUP LIMITED