HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Recommended for repeated use.

For handwashing to decrease bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

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

WHEN USING

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• We hands thoroughly with product
• Brisky rub hands together until dry
• Supervise children under 6 years in the use of this product.

Other information

• May discolor certain fabrics
• Store at the normal temperature

Inactive ingredients

aqua, carbomer 940, trolamine, hydro peroxide, glycerin, fragrance, vitamin e

Package Label - Principal Display Panel

100 mL NDC: 81650-100- 01

250 mL NDC: 81650-100- 02

500 mL NDC: 81650-100- 03

1000 mL NDC: 81650-100- 04

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81650-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)	0.02 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.19 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.33 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.15 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.41 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	20.78 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81650-100-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2021
2	NDC: 81650-100-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2021
3	NDC: 81650-100-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2021
4	NDC: 81650-100-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2021

Labeler - SKYMAX VIETNAM COMPANY LIMITED (555655220)

Registrant - SKYMAX VIETNAM COMPANY LIMITED (555655220)

Establishment
Name	Address	ID/FEI	Business Operations
SKYMAX VIETNAM COMPANY LIMITED		556548577	manufacture(81650-100)