Topcare Therapeutic Anti-dandruff Shampoo
FDA Label NDC 76162-190

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Therapeutic Anti-dandruff (NDC 76162-190). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - ask doctor, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ Otc - Ask Doctor

→ When Using This Product

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 251 Ml Bottle Label

Other

Drug Facts

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

Active Ingredient

Solubilized coal tar extract 2.0% (Coal Tar, 0.5%)

Purpose

Anti-dandruff, anti-seborrheic dematitis, anti-psoriasis

Use

controls the symptom of:

⬥dandruff
⬥seborrheic dermatitis
⬥psoriasis

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if condition covers a large part of the body.

When Using This Product

⬥avoid contact with the 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 this product with other forms of psoriasis therapy such as ultra violet radiation or prescription drugs unless directed to do so by a doctor.

Otc - Stop Use

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Otc - Keep Out Of Reach Of Children

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

Directions

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

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, cocamidopropyl betaine, laureth-4, fragrance, polysorbate 20, citric acid, sodium chloride, disodium EDTA, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.