Hand Sanitizer Vanilla Scent (Alcohol) Gel [Michaels Stores Procurement Company] -

HAND SANITIZER VANILLA SCENT (ALCOHOL) GEL [MICHAELS STORES PROCUREMENT COMPANY]
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NDC	60675-004-00, 60675-004-01, 60675-004-02, 60675-004-03
Set ID	73542d08-1be8-40c6-a298-5860225d30ed
Category	HUMAN OTC DRUG LABEL
Packager	Michaels Stores Procurement Company
Generic Name
Product Class
Product Number
Application Number	PART333E

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Active Ingredient

Ethyl Alcohol 62%
Purpose

Antiseptic
Use
- For hand washing 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. In case of contact with eyes, rinse thoroughly with water.
- Use only as directed. Do not drink. If taken internally, it will produce serious gastric disturbances.
- Stop use and ask a doctor if irritation persists for more than 72 hours.
- Keep out of reach of 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.
- Supervise children in the use of this product.
Other information
- Store below 105 degrees F (40.5 degrees C).
- May discolor some fabrics.
Inactive Ingredients
- carbomer, DandC red n 33, FDandC blue n 1, FDandC yellow n 5, fragrance, glycerin, propylene glycol, triethanolamine, water
Product Labeling

INGREDIENTS AND APPEARANCE

HAND SANITIZER VANILLA SCENT
alcohol gel

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

#	Item Code	Package Description
Packaging
1	NDC:60675-004-00	30 mL in 1 BOTTLE
2	NDC:60675-004-01	30 mL in 1 BOTTLE
3	NDC:60675-004-02	30 mL in 1 BOTTLE
4	NDC:60675-004-03	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/24/2014

Labeler - Michaels Stores Procurement Company (030791425)

Name	Address	ID/FEI	Business Operations
Establishment
Huizhou Yiyani Cosmetic Limited		421321809	manufacture(60675-004)

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