ANTI BACTERIAL HAND SANITIZER- alcohol liquid 
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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Drug Facts

Active Ingredient

Alcohol 62%

Purpose

Antiseptic

Use

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Warnings

■ For external use only ■ Flammable, keep away from fire & flame ■ Does not contain grain alcohol;do not drink. If taken internally will produce serious gastric disturbances

When using this product

■ Avoid the eyes and mucous membranes ■ In the case of eyes or mucous membrane contact, rinse area thoroughly with water

Stop use and ask a doctor if

■ Condition worsens ■ Redness or irritation develops ■ If condition persists for more than 3 days

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions

■ Rub dime sized amount between hands until dry ■ Supervise children in the use of this product ■ In the case of eye contact, rinse eyes thoroughly with water

Other information

■ Store below 105°F ■ May discolor some fabrics

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1, Fragrance, PEG-40 Hydrogenated Castor Oil, Red 4, Red 33, Triethanolamine, Water

Package Label

Package Label

ANTI BACTERIAL  HAND SANITIZER
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60675-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60675-008-3030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/18/2016
Labeler - Michaels Stores Procurement Company (030791425)

Revised: 7/2016
Document Id: 3829a721-7341-1f79-e054-00144ff8d46c
Set id: 3829a721-7340-1f79-e054-00144ff8d46c
Version: 1
Effective Time: 20160721
 
Michaels Stores Procurement Company