Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID bbd72566-c027-4ae1-8de6-8e310d9ad728
Route
TOPICAL
Published
Effective Date 2011-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (.5 mL)
Inactive Ingredients
Water Hydrogenated Polydecene (550 Mw) Alcohol Butylene Glycol Glyceryl Monostearate Peg-100 Stearate Dimethicone Cetyl Alcohol Glycerin Sulfuric Acid Zinc Pidolate Mahonia Aquifolium Fruiting Top Aloe Vera Leaf Malic Acid Sodium Salicylate Levomenol Xanthan Gum Annickia Chlorantha Bark Plantago Lanceolata Leaf Hypericum Perforatum Leaf Oleanolic Acid Almond Lemon Oil Peppermint Oil Polysorbate 80 Phenoxyethanol Methylparaben Butylparaben Ethylparaben Propylparaben Isobutylparaben Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2007-07-15

Description

Active Ingredient Salicylic Acid 1%


Medication Information

Warnings and Precautions

Warnings:

  • For external use only.
  • Avoid contact with eyes and mucous membranes.
  • Discontinue use if signs of rash or irrigation appear.

Indications and Usage

Uses:  Daily treatment cream for acne-prone skin.

Dosage and Administration

Directions:  Apply a dime size amount to cleansed skin with a light massage.  Use morning and night.

Description

Active Ingredient Salicylic Acid 1%

Section 50565-1

Keep out of reach of children.

Section 51727-6

Other Ingredients:  WATER, HYDROGENATED POLYDECENE, ALCOHOL DENAT., BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, DIMETHICONE, CETYL ALCOHOL, GLYCERIN, MAGNESIUM ALUMINUM SULFATE, ZINC PCA, CAPRYLOYL GLYCINE, METHYL METHACRYLATE CROSSPOLYMER, MALIC ACID, SODIUM SALICYLATE, BISABOLOL, XANTHAN GUM, ENANTIA CHLORANTHA BARK EXTRACT, PLANTAGO LANCEOLATA LEAF EXTRACT, HYPERICUM PERFORATUM EXTRACT, OLEANOLIC ACID, HYDROLYZED SWEET ALMOND PROTEIN, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, MENTHA PIPERITA (PEPPERMINT) OIL, BERBERIS AQUIFOLIUM EXTRACT, POLYSORBATE 80, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, SODIUM HYDROXIDE.

Section 51945-4



Section 55105-1

Purpose:  Acne Treatment

Section 55106-9

Active Ingredient

Salicylic Acid 1%


Structured Label Content

Indications and Usage (34067-9)

Uses:  Daily treatment cream for acne-prone skin.

Dosage and Administration (34068-7)

Directions:  Apply a dime size amount to cleansed skin with a light massage.  Use morning and night.

Warnings and Precautions (34071-1)

Warnings:

  • For external use only.
  • Avoid contact with eyes and mucous membranes.
  • Discontinue use if signs of rash or irrigation appear.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Other Ingredients:  WATER, HYDROGENATED POLYDECENE, ALCOHOL DENAT., BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, DIMETHICONE, CETYL ALCOHOL, GLYCERIN, MAGNESIUM ALUMINUM SULFATE, ZINC PCA, CAPRYLOYL GLYCINE, METHYL METHACRYLATE CROSSPOLYMER, MALIC ACID, SODIUM SALICYLATE, BISABOLOL, XANTHAN GUM, ENANTIA CHLORANTHA BARK EXTRACT, PLANTAGO LANCEOLATA LEAF EXTRACT, HYPERICUM PERFORATUM EXTRACT, OLEANOLIC ACID, HYDROLYZED SWEET ALMOND PROTEIN, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, MENTHA PIPERITA (PEPPERMINT) OIL, BERBERIS AQUIFOLIUM EXTRACT, POLYSORBATE 80, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, SODIUM HYDROXIDE.

Section 51945-4 (51945-4)



Section 55105-1 (55105-1)

Purpose:  Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient

Salicylic Acid 1%


Advanced Ingredient Data


Raw Label Data

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