Your browser does not support JavaScript! XTRACARE INSTANT HAND SANITIZER COCOA BUTTER (ALCOHOL) LIQUID [REJOICE INTERNATIONAL]
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XTRACARE INSTANT HAND SANITIZER COCOA BUTTER (alcohol) liquid
[Rejoice International]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph 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

XtraCare instant Hand Sanitizer Cocoa Butter


Active ingredient

Ethyl Alcohol 62.0%

Purpose

Antimicrobial

Uses

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use

Warnings

For external use only.
Flammable, keep away from heat and flame.

Do not use

In the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation and redness develop and persist 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
  • briskly rub hands together until dry
  • supervise children under 6 years in the use of this product 

Other information

  • store at 200C to 250C (680 to 770F)
  • may discolor certain fabrics

Inactive ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, titanium dioxide, cocoa seed butter.

XtraCare

DISTRIBUTED BY: REJOICE INTERNATIONAL INC. 48325 BINGHAMPTON DR, NOTRHVILLE, MI 48168, USA
MADE IN CHINA.

XtraCare  instant Hand Sanitizer Cocoa Butter  kills 99.9% of Germs with Moisturizers and Cocoa Butter  8 fl. oz(236ml)

Product Labels

Cocoa Butter 236 ml

XTRACARE INSTANT HAND SANITIZER COCOA BUTTER  
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
TROLAMINE 
GLYCERIN 
PROPYLENE GLYCOL 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:57337-003-081 in 1 PACKAGE
1236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E02/08/2013
Labeler - Rejoice International (078741245)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Unichem528196956manufacture(57337-003)

Revised: 02/2013
Document Id: f3d5c3f4-d347-41fe-836f-81ec8e750ff0
Set id: 67ad9816-b1be-47f6-9a06-8a05a67a654e
Version: 2
Effective Time: 20130228
 
Rejoice International

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