ANTIBACTERIAL CITRUS SCENT- triclosan soap 
Melaleuca, 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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ABLS Citrus 32 oz Content of Label

Active ingredient
Triclosan 0.3%

Purpose
Antibacterial

Use for handwashing to decrease bacteria on the skin

Warnings
For external use only

When using this product

  • avoid contact with eyes. In case of eye contact, flush with water.
  • discontinue use if signs of irritation or rash appear. If irritation or rash persists for more than three days, consult a physician.

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

Directions

  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly

Inactive ingredients
butylene glycol, citric acid, citrus medica limonum (lemon) peel oil, cocamidopropyl betaine, disodium oleamido MIPA sulfosuccinate, fragrance, glycerin, glycol distearate, helianthus annuus (sunflower) seed oil, melaleuca alternifolia (tea tree) leaf oil (T36-C5® brand), phenoxyethanol, polyquaternium 10 (from starch), potassium sorbate, prunus armeniaca (apricot) kernel oil, simmondsia chinensis (jojoba) seed oil, sodium chloride, sodium coco-sulfate, tocopheryl acetate (vitamin E), water

image of label

ANTIBACTERIAL  CITRUS SCENT
triclosan soap
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54473-143
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL 
ANHYDROUS CITRIC ACID 
LEMON OIL 
COCAMIDOPROPYL BETAINE 
Glycerin 
GLYCOL DISTEARATE 
SUNFLOWER OIL 
Tea Tree Oil 
PHENOXYETHANOL 
POLYQUATERNIUM-10 (400 CPS AT 2%) 
POTASSIUM SORBATE 
APRICOT SEED OIL 
JOJOBA OIL 
SODIUM CHLORIDE 
SODIUM COCO-SULFATE 
ALPHA-TOCOPHEROL ACETATE 
Water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-143-32946 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/200605/15/2014
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.079287544manufacture(54473-143)

Revised: 6/2014
Document Id: 1290ffb5-da99-4557-a6f5-762bea411de6
Set id: 14e34737-030d-47fb-86bc-39328f6e4170
Version: 6
Effective Time: 20140630
 
Melaleuca, Inc.