0ab910cc-3ea9-406a-bcc1-15f1d29a090d

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

Purpose

Psoriasis , dandruff and seborrheic dermatitis

Description

Salicylic Acid 3%


Medication Information

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.

Uses

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

Purpose

Psoriasis , dandruff and seborrheic dermatitis

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

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

Description

Salicylic Acid 3%

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

Structured Label Content

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.

Uses

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

Purpose

Psoriasis , dandruff and seborrheic dermatitis

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

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

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)