SPL v1
SPL
SPL Set ID 230c795d-a0fa-636e-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.01 g)
Inactive Ingredients
Glycerin

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-10-26

Description

Salicylic Acid 1.0%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

for treatment of acne

Dosage and Administration

Topical gel

Description

Salicylic Acid 1.0%

Section 43685-7

Flammable, keep away from open fire or flame

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 50567-7

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

Section 51727-6

Water (Aqua), Alcohol Denat., Glycerin, Salix Nigra (Willow) Bark Extract,Vaccinium Myrtillus Fruit Extract,

Pinus Nigra Bud/Needle Extract, Ribes Nigrum (Black Currant) Fruit Extract, Xanthan Gum, Saccharum Officinarum (Sugar Cane) Extract, Salix Alba (Willow) Bark Extract, Spiraea Ulmaria Flower Extract, Levulinic Acid, Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Sodium Levulinate, Citric Acid, Acer Saccharum (Sugar Maple) Extract

Section 51945-4

Section 55105-1

Acne medication

Section 55106-9

Salicylic Acid 1.0%

Section 59845-8
  • Cleanse skin thoroughly before applying medication
  • Cover the affected area entirely up to 2 times daily
  • If excessinve dryness or peeling occurs, reduce usage to once a day or every other day
  • Recommended for daily use

Structured Label Content

Indications and Usage (34067-9)

for treatment of acne

Dosage and Administration (34068-7)

Topical gel

Warnings and Precautions (34071-1)

For external use only

Section 43685-7 (43685-7)

Flammable, keep away from open fire or flame

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 50567-7 (50567-7)

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

Section 51727-6 (51727-6)

Water (Aqua), Alcohol Denat., Glycerin, Salix Nigra (Willow) Bark Extract,Vaccinium Myrtillus Fruit Extract,

Pinus Nigra Bud/Needle Extract, Ribes Nigrum (Black Currant) Fruit Extract, Xanthan Gum, Saccharum Officinarum (Sugar Cane) Extract, Salix Alba (Willow) Bark Extract, Spiraea Ulmaria Flower Extract, Levulinic Acid, Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Sodium Levulinate, Citric Acid, Acer Saccharum (Sugar Maple) Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne medication

Section 55106-9 (55106-9)

Salicylic Acid 1.0%

Section 59845-8 (59845-8)
  • Cleanse skin thoroughly before applying medication
  • Cover the affected area entirely up to 2 times daily
  • If excessinve dryness or peeling occurs, reduce usage to once a day or every other day
  • Recommended for daily use

Advanced Ingredient Data


Raw Label Data

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