THERAPEUTIC PLUS- coal tar shampoo 
FoodHold U.S.A., LLC

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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Coal Tar Shampoo
205.004/205AG-AH

Active ingredient

2.5% Coal Tar Topical Solution USP

(0.5% Coal Tar)

Purpose

Anti-Dandruff

Use

Controls the symptoms of:

  • dandruff
  • seborrheic dermatitis
  • psoriasis

Warnings

For external use only

Ask a doctor before ue if you have

a condition which covers a large part of the body

When using this product

  • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.
  • use caution in exposing skin to sunlight after applying this product.  It may increase your tendency to sunburn for up to 24 hours after application.
  • do not use for prolonged periods without consulting a doctor
  • do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescriptin dugs unless directed to do so by a doctor

Stop use and ask a doctor if

condition worsens or does not improve after reqular use of this product as directed

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wet hair thoroughly
  • massage shampoo into the scalp
  • lather.  Leave on hair and scalp for several minutes.
  • rinse and repeat
  • for best results use at leat twice a week or as directed by a doctor

Other information

  • store away from direct sunlight
  • in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur

Inactive ingredients

water, sodium laureth sulfate, cocamide MEA, laureth-4, fragrance, sodium chloride, cocamidopropyl betaine, methylchloroisothiazolinone, methylisothiazolinone, citric acid, tetrasodium EDTA, caramel, red 4

Adverse Reactions

DISTRIBUTED BY FOODHOLD U.S.A, LLC

LANDOVER, MD 20785

1-877-846-9949

2013 S+S Brands, LLC

Quality guaranteed or your money back

205.003 205AH

principal display panel

CAREONE

Therapeutic

Shampoo

Coal Tar Anti-Dandruff Shampoo

Controls the symptoms of:

  • Psoriasis
  • Seborrheic Dermatitis
  • Dandruff

Fights Itchy, Flaky Scalp

8.5 FL OZ (251 mL)

image description

THERAPEUTIC PLUS 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
LAURETH-4 (UNII: 6HQ855798J)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CARAMEL (UNII: T9D99G2B1R)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-205-23251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/201309/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/01/201309/19/2023
Labeler - FoodHold U.S.A., LLC (809183973)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(41520-205)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(41520-205)

Revised: 9/2023
 
FoodHold U.S.A., LLC