HAND SANITIZER VANILLA SCENT- alcohol gel
Michaels Stores Procurement Company

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 Vanilla Scent

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

drug facts panel

pdp

HAND SANITIZER VANILLA SCENT
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60675-004
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	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)