Label: ANTI-DANDRUFF- coal tar shampoo
- NDC Code(s): 49348-602-47
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
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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- Active Ingredient
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Warnings
For external use only
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.
- Directions
- Other information
- Inactive ingredients
- disclaimer
- Adverse reaction
- principal display panel
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INGREDIENTS AND APPEARANCE
ANTI-DANDRUFF
coal tar shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-602 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-602-47 251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/21/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 05/21/2005 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(49348-602) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(49348-602)