HAND SANITIZER WITH VITAMIN E- alcohol liquid
K7 Design Group Inc.

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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K7 BBC Hand Sanitizer with VitE

Active ingredient

Alcohol 62%

Purpose

Antiseptic

Use

for hand washing to decrease bacteria on the skin, only when water is not available

Warnings

For external use only. Flammable, keep away from fire and flames

When using this product

■ do not get into eyes. ■ if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

■ irritation and redness develop

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

Inactive ingredients

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

Package Label

package label

HAND SANITIZER WITH VITAMIN E
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74177-027
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
.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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74177-027-30	887 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/29/2020
2	NDC:74177-027-34	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/29/2020
3	NDC:74177-027-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2020
4	NDC:74177-027-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/03/2020
5	NDC:74177-027-28	3789 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/03/2020
6	NDC:74177-027-08	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/14/2020
7	NDC:74177-027-03	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2020
8	NDC:74177-027-50	50 in 1 BOX	09/07/2020
8	NDC:74177-027-07	2 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/29/2020

Labeler - K7 Design Group Inc. (080357784)