NEW SANICOL ADVANCED ANTIBACTERIAL HAND SANITIZER- alcohol gel

NEW SANICOL ADVANCED ANTIBACTERIAL HAND SANITIZER by

Drug Labeling and Warnings

NEW SANICOL ADVANCED ANTIBACTERIAL HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by AM Beauty Distributors Inc., GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 75%

Purpose

Antibacterial 

Use

• Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only: hands

Flammable, keep away from fire or flame.

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 and ask a doctor if 

• irritation or rash develops 
• condition persists for more than 72 hours

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center.

Directions

• Put enough product in palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using SANICOL®

Other information

• Store below 110F (43C)
• May discolor certain fabrics or surfaces

Inactive ingredients:

Water (Aqua), Aloe Barbadensis Leaf Extract, Acrylates/C10-30 alkyl Acrylate Crosspolymer, Tetrahydroxypropyl Ethylenediamine

Package Labeling:

INGREDIENTS AND APPEARANCE

NEW SANICOL ADVANCED ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79254-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETOL (UNII: Q4R969U9FR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79254-019-00	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/10/2020

Labeler - AM Beauty Distributors Inc. (117541993)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO.,LTD		542355899	manufacture(79254-019) , label(79254-019)