Your browser does not support JavaScript! WATERLESS ANTI-BACTERIAL HAND CLEANSER (ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]
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RxNorm Names

WATERLESS ANTI-BACTERIAL HAND CLEANSER (alcohol) liquid
[Tri-Coastal Design Company Inc. ]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

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

Warnings

  • For external use only
  • Flammable, keep away from fire and 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 Use only as directed

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 105F
  • May discolor some fabrics

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49852-180
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
TROLAMINE 
ALOE VERA LEAF 
ALPHA-TOCOPHEROL ACETATE 
D&C RED NO. 33 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49852-180-4545 mL in 1 BOTTLE, PLASTIC
2NDC:49852-180-6060 mL in 1 TUBE
3NDC:49852-180-80237 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/2013
Labeler - Tri-Coastal Design Company Inc. (609734900)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(49852-180)

Revised: 7/2014
 
Tri-Coastal Design Company Inc.

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