PURE SAFER GEL(ETHANOL)- hand sanitizer gel

Pure Safer Gel(Ethanol) by

Drug Labeling and Warnings

Pure Safer Gel(Ethanol) by is a Otc medication manufactured, distributed, or labeled by Sinbad Co.,Ltd, CAREPHARM. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 70.0% v/v

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on skin.

Warnings

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

WHEN USING

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

STOP USE

Stop use and ask doctor if iffitation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN

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

Inactive ingredients

Water(Aqua), Carbomer, Aloe Barbadensis Leaf Juice, Glycerin, Tocopherol, Triethanolamine, Propylene Glycol, FD&C Blue No.1, FD&C Yellow No.5

Directions:

• Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.
• Children under 6 years of age should be supervised when using this product.

Other Information:

• Store below 106°F. (41°C)
• May discolor certain fabrics or surfaces.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

PURE SAFER GEL(ETHANOL) 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74142-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65.6 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.01 mL  in 100 mL
ALOE (UNII: V5VD430YW9)	0.01 mL  in 100 mL
TOCOPHEROL (UNII: R0ZB2556P8)	0.01 mL  in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)	0.19 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.01 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.01 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.01 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	34.14 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74142-201-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/03/2020

Labeler - Sinbad Co.,Ltd (693900611)

Registrant - Sinbad Co.,Ltd (693900611)

Establishment
Name	Address	ID/FEI	Business Operations
CAREPHARM		694639821	manufacture(74142-201)