ANTIBACTERIAL HAND SANITIZER GEL 01- alcohol gel

antibacterial hand sanitizer gel by

Drug Labeling and Warnings

antibacterial hand sanitizer gel by is a Otc medication manufactured, distributed, or labeled by Cosmuses Cosmetics (Ningbo) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Alcohol 62%

Purpose

Antiseptic

Uses

• For hand Sanitizing

Warnings

For external use only- hands.

Flammable. Keep away from heat and flame.

WHEN USING

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

Stop use and ask doctor if skin irritation develops.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Wet hands throughly with product and allow to dry without wiping.
• For children under 6 age use only under adult supervision.
• Not recommended for infants.

STORAGE AND HANDLING

Other information ​

• Do not store above 105 oF.
• May discolor some fabrics.

Inactive Ingredients

Aqua, Butylene Glycol, Aloe Barbadensis Leaf Extract, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER GEL  01
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-022
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE 13576 (UNII: 5EM498GW35)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-022-02	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
2	NDC: 82953-022-05	35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
3	NDC: 82953-022-03	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
4	NDC: 82953-022-06	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
5	NDC: 82953-022-07	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
6	NDC: 82953-022-04	75 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
7	NDC: 82953-022-08	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
8	NDC: 82953-022-01	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
9	NDC: 82953-022-09	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
10	NDC: 82953-022-10	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	05/30/2024

Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-022)