Breakout Clearing Emergency Spot Fix

Breakout Clearing Emergency Spot Fix
SPL v1
SPL
SPL Set ID f1db1790-822e-41b3-af4d-1e28387c090d
Route
TOPICAL
Published
Effective Date 2014-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Water Polyethylene Glycol 400 Green Tea Leaf Glycyrrhiza Glabra Porphyra Umbilicalis Annickia Chlorantha Bark Oleanolic Acid Lavandula Angustifolia Flowering Top Tea Tree Oil Filipendula Ulmaria Root Cetyl Alcohol Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Polysorbate 80 Glyceryl Monostearate Medium-chain Triglycerides Ethylhexylglycerin Butylene Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aminomethylpropanol Xanthan Gum Edetate Disodium Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-06-03

Description

Drug Facts

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Drug Facts

Use
  • For the treatment of acne
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.

Warnings

For external use only

Directions
  • Cleanse the skin thoroughly before applying.
  • Cover the affected area with a thin layer 1 to 3 times a day.
  • Because too much drying of the skin may occur, start with one application daily, and then gradually increase to 2 or 3 times daily if needed or as directed by a physician.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, use a sunscreen. Allow Emergency Spot Fix to dry, then follow directions of the sunscreen labeling.
  • If irritation or sensitivity develops, stop use of both products and ask a doctor.
Do Not Use
  • In or near eyes
  • On broken skin
  • On lips or large areas of the body
  • If you have very sensitive skin
  • If you are sensitive to benzoyl peroxide

Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Active Ingredient

Benzoyl Peroxide (5.0%)

Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Water/Aqua/Eau, PEG-8, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Porphyra Umbilicalis Extract, Enantia Chlorantha Bark Extract, Oleanolic Acid, Lavandula Angustifolia (Lavender) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Spiraea Ulmaria Extract, Cetyl Alcohol, Sodium Acrylate/Sodium Acryloyl Dimethyl Taurate Copolymer, Polysorbate 80, Glyceryl Stearate, Caprylic/Capric Triglyceride, Ethylhexylglycerin, Butylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Xanthan Gum, Disodium EDTA, Phenoxyethanol.

Questions Or Comments

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

When Using This Product
  • Apply to affected areas only.
  • Avoid unnecessary sun exposure and use sunscreen.
  • This product may bleach hair or dyed fabrics.
  • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time.
Stop Use and Ask A Physician
  • If too much skin irritation or sensitivity develops or increases.
Principal Display Panel 9 Ml Tube Carton

dermalogica ®

clear

5%

benzoyl

peroxide

Breakout Clearing

Emergency

Spot Fix

0.3 US FL OZ / 9 mL e


Structured Label Content

Use
  • For the treatment of acne
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.

Purpose

Acne Treatment

Warnings

For external use only

Directions
  • Cleanse the skin thoroughly before applying.
  • Cover the affected area with a thin layer 1 to 3 times a day.
  • Because too much drying of the skin may occur, start with one application daily, and then gradually increase to 2 or 3 times daily if needed or as directed by a physician.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, use a sunscreen. Allow Emergency Spot Fix to dry, then follow directions of the sunscreen labeling.
  • If irritation or sensitivity develops, stop use of both products and ask a doctor.
Do Not Use (Do not use)
  • In or near eyes
  • On broken skin
  • On lips or large areas of the body
  • If you have very sensitive skin
  • If you are sensitive to benzoyl peroxide

Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Active Ingredient (Active ingredient)

Benzoyl Peroxide (5.0%)

Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, PEG-8, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Porphyra Umbilicalis Extract, Enantia Chlorantha Bark Extract, Oleanolic Acid, Lavandula Angustifolia (Lavender) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Spiraea Ulmaria Extract, Cetyl Alcohol, Sodium Acrylate/Sodium Acryloyl Dimethyl Taurate Copolymer, Polysorbate 80, Glyceryl Stearate, Caprylic/Capric Triglyceride, Ethylhexylglycerin, Butylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Xanthan Gum, Disodium EDTA, Phenoxyethanol.

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.
  • Avoid unnecessary sun exposure and use sunscreen.
  • This product may bleach hair or dyed fabrics.
  • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time.
Stop Use and Ask A Physician (Stop use and ask a physician)
  • If too much skin irritation or sensitivity develops or increases.
Principal Display Panel 9 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 9 mL Tube Carton)

dermalogica ®

clear

5%

benzoyl

peroxide

Breakout Clearing

Emergency

Spot Fix

0.3 US FL OZ / 9 mL e


Advanced Ingredient Data


Raw Label Data

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