SPL v1
SPL
SPL Set ID 3f9465db-1c01-0517-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.2 mg)
Inactive Ingredients
Microcrystalline Wax Steareth-21 Polysorbate 60 Potassium Cetyl Phosphate Xanthan Gum Menthyl Lactate, (-)- Hydrolyzed Jojoba Esters (acid Form) Ppg-15 Stearyl Ether Glycolic Acid Water Cetyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-10-01

Description

Active Ingredient - Salicylic Acid 2%


Medication Information

Warnings and Precautions

Warning

For external use only

Indications and Usage

Uses

  • for the treatment of acne
  • clean blackheads
Dosage and Administration

Directions

  • Wet face
  • gently massage all over face for 20-30 seconds
  • rinse thoroughly and pat dry
  • recommended for daily use
Description

Active Ingredient - Salicylic Acid 2%

Section 50565-1

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Section 50567-7

When using this product and other topical acne medication at the same time or immediately following the use of this product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor

Section 51727-6

Water, Cetyl Alcohol, PPG-15 Stearyl Ether, Glycolic Acid, Microcrystalline wax, Steareth - 21, Polysorbate 60, potassium cetyl phosphate, xanthan gum, fragrance, menthyl lactate, jojoba esters

Section 51945-4

Section 55105-1

Purpose - Acne Treatment

Section 55106-9

Active Ingredient - Salicylic Acid 2%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the treatment of acne
  • clean blackheads
Dosage and Administration (34068-7)

Directions

  • Wet face
  • gently massage all over face for 20-30 seconds
  • rinse thoroughly and pat dry
  • recommended for daily use
Warnings and Precautions (34071-1)

Warning

For external use only

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 50567-7 (50567-7)

When using this product and other topical acne medication at the same time or immediately following the use of this product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor

Section 51727-6 (51727-6)

Water, Cetyl Alcohol, PPG-15 Stearyl Ether, Glycolic Acid, Microcrystalline wax, Steareth - 21, Polysorbate 60, potassium cetyl phosphate, xanthan gum, fragrance, menthyl lactate, jojoba esters

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose - Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient - Salicylic Acid 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)