PURE AND SAFE HAND SANITIZER PLUS GEL- alcohol gel

Pure And Safe Hand Sanitizer Plus Gel by

Drug Labeling and Warnings

Pure And Safe Hand Sanitizer Plus Gel by is a Otc medication manufactured, distributed, or labeled by COSCOS LLC, WHAIN COSMETIC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient[s]

Alcohol 62%

Purpose

Antiseptic

Use[s]

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.

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.

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine, Sodium Hyaluronate, Butylene Glycol, Camellia Sinensis Leaf Extract, Artemisia Princeps Extract

Package Label

INGREDIENTS AND APPEARANCE

PURE AND SAFE HAND SANITIZER PLUS GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77123-201
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ARTEMISIA PRINCEPS WHOLE (UNII: 2849G48V9J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77123-201-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/12/2020

Labeler - COSCOS LLC (122642799)

Registrant - COSCOS LLC (122642799)

Establishment
Name	Address	ID/FEI	Business Operations
COSCOS LLC		122642799	label(77123-201)

Establishment
Name	Address	ID/FEI	Business Operations
WHAIN COSMETIC		557837595	manufacture(77123-201)