Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 720ee542-01a9-4aa5-b95c-571e947fbac7
Route
TOPICAL
Published
Effective Date 2010-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (50 mg)

Identifiers & Packaging

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

Description

INDICATIONS AND USAGE SECTION: An aha/bha blended acne masque designed to immediately draw out impurities and excess oil. Anti-oxidant blends of nutrients soothe irritated and red acne lesions. This amazing masque leaves skin fresh and oil-free. Paraben-free DIRECTIONS : Apply to cleansed skin for 5-15 minutes, remove with tepid water, followed by a cold water splash. May be used as a spot treatment for active lesions. INDICATIONS: Acne and acne-prone skin


Medication Information

Indications and Usage

INDICATIONS AND USAGE SECTION:

An aha/bha blended acne masque designed to immediately draw out impurities and excess oil. Anti-oxidant blends of nutrients soothe irritated and red acne lesions. This amazing masque leaves skin fresh and oil-free.

Paraben-free



DIRECTIONS:

Apply to cleansed skin for 5-15 minutes, remove with tepid water, followed by a cold water splash. May be used as a spot treatment for active lesions.



INDICATIONS:

Acne and acne-prone skin

Description

INDICATIONS AND USAGE SECTION: An aha/bha blended acne masque designed to immediately draw out impurities and excess oil. Anti-oxidant blends of nutrients soothe irritated and red acne lesions. This amazing masque leaves skin fresh and oil-free. Paraben-free DIRECTIONS : Apply to cleansed skin for 5-15 minutes, remove with tepid water, followed by a cold water splash. May be used as a spot treatment for active lesions. INDICATIONS: Acne and acne-prone skin

Section 51727-6

INACTIVE INGREDIENTS:

Aqua (water), Magnesium Aluminum Silicate, Kaolin, Glycolic acid, Dimethyl Sulfone, Aloe vera gel, Glycerin, Sorbitol, Melaleuca alternifolia leaf oil (Tea Tree Oil), Sodium Polystyrene Sulfonate, Algae Extract, Cucumis sativus (Cucumber) fruit extract, Panthenol, Extracts of Malva sylvestris (Mallow), Mentha piperita (Peppermint Leaf), Primula veris, Alchemilla vulgaris, Veronica officinalis, Melissa officinalis leaf, Achillea millefolium, Titanium Dioxide, Sodium Hyaluronate, Caprylyl glycol and Phenoxyethanol and Hexylene glycol, Triethanolamine, Chamomilla recutita flower extract,  Rosemarinus officinalis leaf extract, Melia azadirachta leaf extract, Camellia sinensis leaf extract , Hydrolyzed wheat protein, Spiraea ulmaria Flower Extract (and) Centella asiatica extract (and) amino acids, Xanthan Gum, Leptospermum scoparium oil (Manuka oil), Eucalyptus globulus leaf oil, Allantoin, Disodium EDTA.

Section 51945-4

DISTRIBUTOR:

Image International

Palm Beach, FL 33411 USA

www.imageskincare.com



IMAGE OF PRINCIPAL DISPLAY PANEL:

Section 55106-9
ACTIVE INGREDIENTS:



Salicylic Acid


Structured Label Content

Indications and Usage (34067-9)

INDICATIONS AND USAGE SECTION:

An aha/bha blended acne masque designed to immediately draw out impurities and excess oil. Anti-oxidant blends of nutrients soothe irritated and red acne lesions. This amazing masque leaves skin fresh and oil-free.

Paraben-free



DIRECTIONS:

Apply to cleansed skin for 5-15 minutes, remove with tepid water, followed by a cold water splash. May be used as a spot treatment for active lesions.



INDICATIONS:

Acne and acne-prone skin

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:

Aqua (water), Magnesium Aluminum Silicate, Kaolin, Glycolic acid, Dimethyl Sulfone, Aloe vera gel, Glycerin, Sorbitol, Melaleuca alternifolia leaf oil (Tea Tree Oil), Sodium Polystyrene Sulfonate, Algae Extract, Cucumis sativus (Cucumber) fruit extract, Panthenol, Extracts of Malva sylvestris (Mallow), Mentha piperita (Peppermint Leaf), Primula veris, Alchemilla vulgaris, Veronica officinalis, Melissa officinalis leaf, Achillea millefolium, Titanium Dioxide, Sodium Hyaluronate, Caprylyl glycol and Phenoxyethanol and Hexylene glycol, Triethanolamine, Chamomilla recutita flower extract,  Rosemarinus officinalis leaf extract, Melia azadirachta leaf extract, Camellia sinensis leaf extract , Hydrolyzed wheat protein, Spiraea ulmaria Flower Extract (and) Centella asiatica extract (and) amino acids, Xanthan Gum, Leptospermum scoparium oil (Manuka oil), Eucalyptus globulus leaf oil, Allantoin, Disodium EDTA.

Section 51945-4 (51945-4)

DISTRIBUTOR:

Image International

Palm Beach, FL 33411 USA

www.imageskincare.com



IMAGE OF PRINCIPAL DISPLAY PANEL:

Section 55106-9 (55106-9)
ACTIVE INGREDIENTS:



Salicylic Acid


Advanced Ingredient Data


Raw Label Data

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