XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING- triclosan soap 
Rejoice International, 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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Active Ingredient                                    Purpose

Triclosan 0.15%...................................Antibacterial

Uses

for hand washing to decrease bacteria on the skin.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Antibacterial Moisturizing Hand Soap

Mountain Spring Scent

Warnings

for external use only.

When using this product avoid contact with eyes.  In case of eye contact, flush with water.

Stop use and ask a doctor if irritation and redness develops.

Directions

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone, fd&c blue no. 1.

Other information

DISTRIBUTED BY:

REJOICE INTERNATIONAL, INC.

48325 BINGHAMPTON DR., NORTHVILLE, MI 48168, USA

MADE IN CHINA

label image

XTRACARE ANTIBACTERIAL HAND CLEANSE  MOUNTAIN SPRING
triclosan soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-020
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3.3 mg  in 221 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57337-020-01 221 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/03/2013
Labeler - Rejoice International, Inc. (078741245)
Establishment
Name Address ID/FEI Business Operations
China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(57337-020)

Revised: 9/2013
Document Id: 048b18ef-f03e-4be7-af8b-58f69460ae35
Set id: c31723d5-a313-448a-8b69-ca5f8dec25ed
Version: 3
Effective Time: 20130917
 
Rejoice International, Inc.