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Name:Antibacterialsparkling Mist
Manufacturer:Sam's West Inc
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

ANTIBACTERIAL SPARKLING MIST - triclosan solution 
SAM'S WEST 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

TRICLOSAN  0.15%

PURPOSE

ANTIBACTERIAL

USE

FOR WASHING TO DECREASE BACTERIA ON THE SKIN

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOP.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON CONTROL IMMEDIATELY.

DIRECTIONS

SQUEEZE ONTO WET HANDS OR BODY SPONGE, WORK INTO LATHER, WASH SKIN,RINSE AND DRY THOROUGHLY.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-8, FRAGRANCE, GLYCERIN, ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE, POLYQUATERNIUM-10, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID, PROPYLENE GLYCOL, NIACINAMIDE, HIBISCUS, SADARIFFA FLOWER EXTRACT, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, TETRASODIUM EDTA, SODIUM CHLORIDE, BLUE1, RED 33

Image of label


ANTIBACTERIAL  SPARKLING MIST
triclosan solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-804
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 0.15 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
SODIUM LAURETH SULFATE  
COCAMIDOPROPYL BETAINE  
PEG-8 DIOLEATE  
GLYCERIN  
INDELOXAZINE HYDROCHLORIDE  
POLYQUATERNIUM-10 (400 CPS AT 2%)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE  
DMDM HYDANTOIN  
CITRIC ACID MONOHYDRATE  
PROPYLENE GLYCOL  
NIACINAMIDE  
HIBISCUS SABDARIFFA FLOWER  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
VITAMIN A PALMITATE  
ASCORBYL PALMITATE  
GREEN TEA LEAF  
EDETATE SODIUM  
GINGER  
CHAMAEMELUM NOBILE FLOWER  
SODIUM CHLORIDE  
FD&C BLUE NO. 1  
D&C RED NO. 33  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68196-804-24 720 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 06/17/2011

Labeler - SAM'S WEST INC (051957769)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture

Revised: 06/2011 SAM'S WEST INC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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