HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Davemed Healthcare Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70% v/v

USES

To decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

WARNING:

Flammable.

Keep away from fire or flame.

For external use of onlyh.

WHEN USING THIS PRODUCT:

avoid contact with eyes in case of eye contact immediately flush eyes with water, call a doctor avoid contact with broken skin.

STOP USE AND ASK A DOCTOR:

Discontinue use if irritation or redness develos, If condition persists from more than 72 hours, consult a doctor

KEEP OUT OF CHILDREN:

Children should only use this product under adult supervision

DIRECTIONS:

• Place enough product in your palm to thoroughly spread on both hands and rub into the skin undil dry Recommended for repeated use.

INGREDIENTS:

Water, Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Peg-40, Hydrogenated Castor Oil, Parfum, Triethanolamine

PURPOSE

Antiseptic

OTHER SAFETY INFORMATION

Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

OTHER SAFETY INFORMATION

• Store between 15-30C
• Avoid freezing and excessive heat above 40C (104F)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70897-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-40 SORBITAN DIISOSTEARATE (UNII: JL4CCU7I1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70897-012-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
2	NDC: 70897-012-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
3	NDC: 70897-012-03	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
4	NDC: 70897-012-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
5	NDC: 70897-012-05	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
6	NDC: 70897-012-06	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
7	NDC: 70897-012-07	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
8	NDC: 70897-012-08	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
9	NDC: 70897-012-09	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
10	NDC: 70897-012-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
11	NDC: 70897-012-11	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
12	NDC: 70897-012-12	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/30/2020

Labeler - Davemed Healthcare Co., Ltd (529128716)

Establishment
Name	Address	ID/FEI	Business Operations
Davemed Healthcare Co., Ltd		529128716	manufacture(70897-012)