DG BODY ANTIBACTERIAL HAND- triclosan soap 
DOLGENCORP 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

Uses

Helps reduce 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 a doctor if

irritation or redness develops and lasts.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

Apply onto wet hands, work into a lather. Rinse thoroughly

Other information

Store at room temperature

Inactive ingredients

Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamidopropyl Hydroxysultaine, Glycerin, Fragrance (Parfum), Polyquaternium-7, PPG-2 Hydroxyethyl Coco/Isostearamide, DMDM Hydantoin, Tetrasodium EDTA, Citric Acid, Yellow 5 (CI 19140), Red 4 (CI 14700)

Label Copy

Image of the label

DG BODY  ANTIBACTERIAL HAND
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-294
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE (UNII: EK4J71ZKEQ)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-294-07222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/26/2015
Labeler - DOLGENCORP INC (068331990)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(55910-294)

Revised: 8/2015
Document Id: 173f5bf7-2c20-4dc6-96c7-7cf319b89451
Set id: 61d21cf9-9e24-496a-832a-92ac63529fea
Version: 1
Effective Time: 20150827
 
DOLGENCORP INC