Overnight Clearing Gel

Overnight Clearing Gel
SPL v3
SPL
SPL Set ID 6f6d9bd9-a1c8-4f8c-b7b8-fe9748a06c2c
Route
TOPICAL
Published
Effective Date 2017-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Polyethylene Glycol 1500 Butylene Glycol Polysorbate 20 Glycerin Peg-60 Almond Glycerides Berberis Aquifolium Root Rosemary Camellia Oleifera Leaf Filipendula Ulmaria Root Horse Chestnut Crithmum Maritimum Yeast, Unspecified Hyaluronate Sodium Biotin Panthenol Caffeine Niacinamide Glycyrrhizinate Dipotassium Camphor (synthetic) 10-hydroxydecanoic Acid Sebacic Acid 1,10-decanediol Masoprocol Oleanolic Acid Xanthan Gum Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Polyoxyl 40 Hydrogenated Castor Oil Ammonium Glycyrrhizate Zinc Gluconate Zinc Acetate Sodium Hydroxide Medium-chain Triglycerides Chlorphenesin Caprylyl Glycol Phenoxyethanol Tea Tree Oil Rosemary Oil Palmarosa Oil Peppermint Oil Citrus Maxima Fruit Rind Oil Lemon Oil Fennel Oil Spearmint Oil Pelargonium Graveolens Flower Oil Eucalyptus Oil Ginger Oil Artemisia Vulgaris Top Oil Litsea Oil White Pepper Oil Nutmeg Oil Basil Oil Citronella Oil Cinnamon Bark Oil Orange Oil Lavender Oil Sage Oil Thyme Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2007-05-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a Doctor if rash occurs.

Section 50570-1

Do not use on broken skin or on large areas of the body.

Section 55105-1
  • For the treatment of acne.
Warnings

For external use only.

Directions
  • Clean the skin thoroughly before applying.
  • Cover the affected area with a thin layer at night.
  • Because too much drying of the skin may occur, start with 1 application daily at night, and if bothersome dryness or peeling occurs, reduce application to 2 to 3 times per week.
Active Ingredients

Salicylic Acid 2.0%

Inactive Ingredients

Water (Aqua), PEG-32, Butylene Glycol, Salicylic Acid, PVM/MA Decadiene Crosspolymer, Polysorbate 20, Glycerin, PEG-60 Almond Glycerides, Mahonia Aquifolium Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Camellia Oleifera Leaf Extract, Spiraea Ulmaria Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Crithmum Maritimum Extract, Yeast Extract, Hydrogenated Vegetable Oil, Sodium Hyaluronate, Biotin, Panthenol, Caffeine, Niacinamide, Dipotassium Glycyrrhizate, Camphor, 10-Hydroxydecanoic Acid, Sebacic Acid, 1,10-Decanediol, Nordihydroquaiaretic Acid, Oleanolic Acid, Xanthan Gum, Carbomer, PEG-40 Hydrogenated Castor Oil, Ammonium Glycyrrhizate, Zinc Gluconate, Zinc Acetate, Sodium Hydroxide, Caprylic/Capric Triglyceride, Chlorphenesin, Caprylyl Glycol, Phenoxyethanol, Limonene, Linalool, Geraniol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Cymbopogon Martini Oil, Mentha Piperita (Peppermint) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Mentha Viridis (Spearmint) Leaf Oil, Pelargonium Graveolens Flower Oil, Eucalyptus Globulus Leaf Oil, Zingiber Officinale (Ginger) Root Oil, Artemisia Vulgaris Oil, Litsea Cubeba Fruit Oil, Piper Nigrum (Pepper) Seed Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Ocimum Basilicum (Basil) Oil, Cymbopogon Nardus (Citronella) Oil, Cinnamomum Zeylanicum Bark Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Salvia Officinalis (Sage) Oil, Thymus Vulgaris (Thyme) Oil.

Questions Or Comments

Call toll free 1-800-831-5150 in the US.

When Using This Product
  • Apply to affected areas only
  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Avoid unnecessary sun exposure and use a sunscreen.

Principal Display Panel 50 Ml Bottle Carton

overnight

clearing

gel

acne treatment

mediBac clearing®

1.7 US FL OZ

50 mL e

dermalogica ®


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and ask a Doctor if rash occurs.

Section 50570-1 (50570-1)

Do not use on broken skin or on large areas of the body.

Section 55105-1 (55105-1)
  • For the treatment of acne.
Warnings

For external use only.

Directions
  • Clean the skin thoroughly before applying.
  • Cover the affected area with a thin layer at night.
  • Because too much drying of the skin may occur, start with 1 application daily at night, and if bothersome dryness or peeling occurs, reduce application to 2 to 3 times per week.
Active Ingredients

Salicylic Acid 2.0%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), PEG-32, Butylene Glycol, Salicylic Acid, PVM/MA Decadiene Crosspolymer, Polysorbate 20, Glycerin, PEG-60 Almond Glycerides, Mahonia Aquifolium Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Camellia Oleifera Leaf Extract, Spiraea Ulmaria Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Crithmum Maritimum Extract, Yeast Extract, Hydrogenated Vegetable Oil, Sodium Hyaluronate, Biotin, Panthenol, Caffeine, Niacinamide, Dipotassium Glycyrrhizate, Camphor, 10-Hydroxydecanoic Acid, Sebacic Acid, 1,10-Decanediol, Nordihydroquaiaretic Acid, Oleanolic Acid, Xanthan Gum, Carbomer, PEG-40 Hydrogenated Castor Oil, Ammonium Glycyrrhizate, Zinc Gluconate, Zinc Acetate, Sodium Hydroxide, Caprylic/Capric Triglyceride, Chlorphenesin, Caprylyl Glycol, Phenoxyethanol, Limonene, Linalool, Geraniol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Cymbopogon Martini Oil, Mentha Piperita (Peppermint) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Mentha Viridis (Spearmint) Leaf Oil, Pelargonium Graveolens Flower Oil, Eucalyptus Globulus Leaf Oil, Zingiber Officinale (Ginger) Root Oil, Artemisia Vulgaris Oil, Litsea Cubeba Fruit Oil, Piper Nigrum (Pepper) Seed Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Ocimum Basilicum (Basil) Oil, Cymbopogon Nardus (Citronella) Oil, Cinnamomum Zeylanicum Bark Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Salvia Officinalis (Sage) Oil, Thymus Vulgaris (Thyme) Oil.

Questions Or Comments (Questions or comments)

Call toll free 1-800-831-5150 in the US.

When Using This Product (When using this product)
  • Apply to affected areas only
  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Avoid unnecessary sun exposure and use a sunscreen.

Principal Display Panel 50 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton)

overnight

clearing

gel

acne treatment

mediBac clearing®

1.7 US FL OZ

50 mL e

dermalogica ®


Advanced Ingredient Data


Raw Label Data

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