Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 2f7f676e-5517-4b18-8c97-f7f019a36913
Route
TOPICAL
Published
Effective Date 2010-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2.0 g)
Inactive Ingredients
Yellow Wax Microcrystalline Wax Candelilla Wax Tea Tree Oil Ethylhexyl Palmitate Mineral Oil Camphor Oil Isopropyl Myristate Petrolatum Mica Butylated Hydroxytoluene Benzyl Alcohol Methylchloroisothiazolinone Methylisothiazolinone Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-12-01

Description

Active Ingredient: Salicylic Acid 2.0%


Medication Information

Warnings and Precautions

Warning:

For external use only

Indications and Usage

Uses:

  • Conceal and heal acn for on the spot treatment

  • Medicated formula with active salicylic acid and tea tree oil heels and clears blemishes
  • Provides natural looking coverage under or above makeup so blemishes disappear

Dosage and Administration

Directions:

Use the conceal side of the pencil to cover up any unwanted blemishes and imperfections. Use the blend brush to work the formula into the skin to create a beautiful and even coverage.

Description

Active Ingredient: Salicylic Acid 2.0%

Section 44425-7

Other Information:

Store at room temperature 20-25C (68-77F)

Section 50565-1

Keep Out of Reach of Children:

If swallowed get medical help or contact a Poison Control Center immediately

Section 50567-7

When Using This Product:

Avoid using other topical products on the same area unless otherwise directed by your doctor

Avoid using salicylic acid on wounds or on areas of eczema

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Section 50569-3

Tell Your Doctor And Pharmacist If

You are allergic to salicylic acid or any other medications

Section 51727-6

Inactive Ingredient:

Synthetic Beeswax, Microstalline Wax, Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Castor Oil, Ethylhexy Palmitate, Paraffinium Liquidum (Mineral Oil), Bis-Diglyceryl Polyacyladipate-2, Isopropyl Myristate, Petrolatum, Mica, Melaleuca Alternafolia (Tea Tree) Leaf Oil, BHT, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone.



May Contain:



Iron Oxide (CI77491, CI77492, CI77499), Titanium Dioxide

Section 51945-4

lab

Section 55105-1

Purpose:

Anti-Acne

Section 55106-9

Active Ingredient:

Salicylic Acid 2.0%


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Conceal and heal acn for on the spot treatment

  • Medicated formula with active salicylic acid and tea tree oil heels and clears blemishes
  • Provides natural looking coverage under or above makeup so blemishes disappear

Dosage and Administration (34068-7)

Directions:

Use the conceal side of the pencil to cover up any unwanted blemishes and imperfections. Use the blend brush to work the formula into the skin to create a beautiful and even coverage.

Warnings and Precautions (34071-1)

Warning:

For external use only

Section 44425-7 (44425-7)

Other Information:

Store at room temperature 20-25C (68-77F)

Section 50565-1 (50565-1)

Keep Out of Reach of Children:

If swallowed get medical help or contact a Poison Control Center immediately

Section 50567-7 (50567-7)

When Using This Product:

Avoid using other topical products on the same area unless otherwise directed by your doctor

Avoid using salicylic acid on wounds or on areas of eczema

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Section 50569-3 (50569-3)

Tell Your Doctor And Pharmacist If

You are allergic to salicylic acid or any other medications

Section 51727-6 (51727-6)

Inactive Ingredient:

Synthetic Beeswax, Microstalline Wax, Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Castor Oil, Ethylhexy Palmitate, Paraffinium Liquidum (Mineral Oil), Bis-Diglyceryl Polyacyladipate-2, Isopropyl Myristate, Petrolatum, Mica, Melaleuca Alternafolia (Tea Tree) Leaf Oil, BHT, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone.



May Contain:



Iron Oxide (CI77491, CI77492, CI77499), Titanium Dioxide

Section 51945-4 (51945-4)

lab

Section 55105-1 (55105-1)

Purpose:

Anti-Acne

Section 55106-9 (55106-9)

Active Ingredient:

Salicylic Acid 2.0%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)