Label: THERAPEUTIC- coal tar shampoo
- NDC Code(s): 55316-205-23
- Packager: DZA Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 6, 2023
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- Claims
- Active ingredients
- Purpose
- Use
- Warnings
- Ask a doctor before use if you have
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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 prescription drugs unless directed to do so by a doctor
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- other information
- Inactive ingredients
- Disclaimer
- Adverse Reactions
- principal display panel
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INGREDIENTS AND APPEARANCE
THERAPEUTIC
coal tar shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCO DIETHANOLAMIDE (UNII: 92005F972D) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:55316-205-23 1 in 1 CARTON 05/08/2008 1 251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 05/08/2008 Labeler - DZA Brands, LLC (090322194) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55316-205) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55316-205)