WATERLESS ANTI-BACTERIAL HAND CLEANSER - alcohol liquid 
Tri-Coastal Design Company 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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Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

Warnings

When using this product

Stop use and ask a doctor if

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions

Other information

Inactive Ingredients

Water (Aqua), Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Gel, Tocopheryl Acetate, Fragrance (Parfum), DC Red 33, FDC Blue 1

Package Label

image description

WATERLESS ANTI-BACTERIAL HAND CLEANSER 
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49852-180
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49852-180-45 45 mL in 1 BOTTLE, PLASTIC
2 NDC:49852-180-60 60 mL in 1 TUBE
3 NDC:49852-180-80 237 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/15/2013
Labeler - Tri-Coastal Design Company Inc. (609734900)
Establishment
Name Address ID/FEI Business Operations
Ningbo Pulisi Daily Chemical Products Co.,Ltd. 529047265 manufacture(49852-180)

Revised: 7/2014
Document Id: 5b683090-237e-42c4-b896-a8deb84c1a59
Set id: d183e8a2-7770-4468-9228-a5c8ea4ff9d2
Version: 3
Effective Time: 20140729
 
Tri-Coastal Design Company Inc.