SPL v1
SPL
SPL Set ID 0ab910cc-3ea9-406a-bcc1-15f1d29a090d
Route
TOPICAL
Published
Effective Date 2023-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 g)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Peg-120 Methyl Glucose Dioleate Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Trolamine Panthenol .alpha.-tocopherol Acetate Tea Tree Oil Green Tea Leaf Ascorbic Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-03-08

Description

Salicylic Acid 3%

Purpose

Psoriasis , dandruff and seborrheic dermatitis


Medication Information

Purpose

Psoriasis , dandruff and seborrheic dermatitis

Description

Salicylic Acid 3%

Uses

Relieves and helps prevent recurrence of scalp irritation, flaking , itching, redness , scaling

Warnings

For external use only

Do not use

  • On damaged or inflamed scalp
  • if you are allergic to ingredients in this product

When using this product 

  • Avoid contact with eyes
  • if contact occurs, rinse the eyes thoroughly with water

Stop use and ask a doctor if 

  • rash appears 
  • condition worsens or does not improve in 2-4 weeks.

If pregnant or breast-feeding, ask a doctor use.

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

Directions

Adults and children aged 12 and over :

  • wet hair thoroughly 
  • apply shampoo, generously lather, then rinse thoroughly. Repeate.
  • Use every 3-4 days for up to 8 weeks or as direacted by a doctor. Then use only as needed to control dandruff

Cildren under 12 years old

  • ask a doctor

Product Label

Active Ingredient

Salicylic Acid 3%

Other Information 
  • store between 20° - 25°C (68° - 77°F)
  • see bottom panel for lot number and expiration date
Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Peg-120 Methyl Glucose Dioleate, Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw), Trolamine, Panthenol, .Alpha.-Tocopherol Acetate, Tea Tree Oil, Green Tea Leaf, Ascorbic Acid


Structured Label Content

Uses

Relieves and helps prevent recurrence of scalp irritation, flaking , itching, redness , scaling

Purpose

Psoriasis , dandruff and seborrheic dermatitis

Warnings

For external use only

Do not use

  • On damaged or inflamed scalp
  • if you are allergic to ingredients in this product

When using this product 

  • Avoid contact with eyes
  • if contact occurs, rinse the eyes thoroughly with water

Stop use and ask a doctor if 

  • rash appears 
  • condition worsens or does not improve in 2-4 weeks.

If pregnant or breast-feeding, ask a doctor use.

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

Directions

Adults and children aged 12 and over :

  • wet hair thoroughly 
  • apply shampoo, generously lather, then rinse thoroughly. Repeate.
  • Use every 3-4 days for up to 8 weeks or as direacted by a doctor. Then use only as needed to control dandruff

Cildren under 12 years old

  • ask a doctor

Product Label (Product label)

Active Ingredient

Salicylic Acid 3%

Other Information 
  • store between 20° - 25°C (68° - 77°F)
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Peg-120 Methyl Glucose Dioleate, Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw), Trolamine, Panthenol, .Alpha.-Tocopherol Acetate, Tea Tree Oil, Green Tea Leaf, Ascorbic Acid


Advanced Ingredient Data


Raw Label Data

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