SPL v2
SPL
SPL Set ID c766afe3-3c55-433f-b2cb-b681da734294
Route
TOPICAL
Published
Effective Date 2011-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1.1 g)
Inactive Ingredients
Yellow Wax Coccinia Grandis Fruit Edetic Acid Holarrhena Pubescens Bark Azadirachta Indica Leaf Propylene Glycol Sesame Oil Sodium Lauryl Sulfate Methylparaben Sodium Propylparaben Sodium Stearic Acid Trolamine Polysorbate 60 Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-01-02

Description

Salicylic Acid 2%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

controls, fights, and helps prevent skin itching, irritation, redness, flaking and scaling associated with:

  • psoriasis
  • seborrheic dermatitis

Dosage and Administration


  • apply liberally to affected areas one to four times daily or as directed by a doctor
  • children under 2 years of age: consult a doctor

Description

Salicylic Acid 2%

Section 44425-7

store in a cool and dry place

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product

  • avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water
  • if you currently use steroids or have used steroids in the recent past, it may take 1 to 3 months to see results

Section 50569-3

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

Section 50570-1

Do not use if you are allergic to sesame oil.

Section 51727-6

Beeswax, Carbomer, Cetyl Alcohol, Coccinia Indica fruit extract, EDTA, Fragrance, Glyceryl Stearate, Holarrhena Antidysenterica leaf extract, Melia Azadirachta leaf extract, Propylene Glycol, Sesamum Indicum (Sesame) seed oil, Sodium Lauryl Sulfate, Sodium Methylparaben, Sodium Propylparaben, Stearic Acid, Triethanolamine, Polysorbate 60, White soft paraffin

Section 51945-4

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1

Psoriasis, Seborrheic Dermatitis

Section 55106-9

Salicylic Acid 2%


Structured Label Content

Indications and Usage (34067-9)

controls, fights, and helps prevent skin itching, irritation, redness, flaking and scaling associated with:

  • psoriasis
  • seborrheic dermatitis

Dosage and Administration (34068-7)


  • apply liberally to affected areas one to four times daily or as directed by a doctor
  • children under 2 years of age: consult a doctor

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

store in a cool and dry place

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water
  • if you currently use steroids or have used steroids in the recent past, it may take 1 to 3 months to see results

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use if you are allergic to sesame oil.

Section 51727-6 (51727-6)

Beeswax, Carbomer, Cetyl Alcohol, Coccinia Indica fruit extract, EDTA, Fragrance, Glyceryl Stearate, Holarrhena Antidysenterica leaf extract, Melia Azadirachta leaf extract, Propylene Glycol, Sesamum Indicum (Sesame) seed oil, Sodium Lauryl Sulfate, Sodium Methylparaben, Sodium Propylparaben, Stearic Acid, Triethanolamine, Polysorbate 60, White soft paraffin

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Psoriasis, Seborrheic Dermatitis

Section 55106-9 (55106-9)

Salicylic Acid 2%


Advanced Ingredient Data


Raw Label Data

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