HAND SANITIZER- alcohol gel
CMC Group Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand Sanitizer

Drug Facts

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin
Recommended for repeated use.

Warnings

Flammable, keep away from fire or flame

For external use only.

Do not use

in the eyes.

Stop use and ask a doctor if

irritation and redness develop
condition persists for more than 72 hours

Keep out of reach children.

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

Carbomer, propylene glycol, purified water, titanium dioxide

Package Labeling

49687-0015-0 49687-0015-1

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49687-0015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49687-0015-1	6 in 1 BOX	08/08/2016
1		0.9 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:49687-0015-0	6 in 1 KIT	08/08/2016	08/08/2016
2		0.9 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/08/2016

Labeler - CMC Group Inc. (117201448)