INSTANT HAND SANITIZER- alcohol gel

INSTANT HAND SANITIZER by

Drug Labeling and Warnings

INSTANT HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Double Body Biotech Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Alcohol 75%

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use.

• In children less than 2 months of age
• On open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

Directions

Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping, Children under 6 years of age should be supervised when using this product.

Other information

Store below 106F 41C

Inactive ingredients

water

aloe barbadensis extract

carbomer

glycerin

sodium hydroxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74657-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74657-002-01	29.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
2	NDC: 74657-002-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
3	NDC: 74657-002-03	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
4	NDC: 74657-002-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
5	NDC: 74657-002-05	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/18/2020
6	NDC: 74657-002-06	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/18/2020
7	NDC: 74657-002-07	350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/18/2020
8	NDC: 74657-002-08	400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/18/2020
9	NDC: 74657-002-09	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/18/2020
10	NDC: 74657-002-10	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/18/2020
11	NDC: 74657-002-11	2 mL in 1 BAG; Type 0: Not a Combination Product	06/18/2020
12	NDC: 74657-002-12	4 mL in 1 BAG; Type 0: Not a Combination Product	06/18/2020
13	NDC: 74657-002-13	5 mL in 1 BAG; Type 0: Not a Combination Product	06/18/2020
14	NDC: 74657-002-14	10 mL in 1 BAG; Type 0: Not a Combination Product	06/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/18/2020

Labeler - Double Body Biotech Limited (560246954)

Establishment
Name	Address	ID/FEI	Business Operations
Double Body Biotech Limited		560246954	manufacture(74657-002)