Breakout Clearing Emergency Spot Fix description, usages, side effects, indications, overdosage, supplying and lots more!

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Breakout Clearing Emergency Spot Fix

Dermalogica, Inc.

Breakout Clearing Emergency Spot Fix


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Benzoyl Peroxide (5.0%)

Purpose

Acne Treatment

Use

  • For the treatment of acne

Warnings

For external use only

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.

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.

Keep out of reach of children.

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

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.

Breakout Clearing Emergency Spot Fix 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

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

Breakout Clearing Emergency Spot Fix

Breakout Clearing Emergency Spot Fix

Benzoyl Peroxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68479-202
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 50 mg

Inactive Ingredients

Ingredient Name Strength
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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 9 in 1 TUBE
2 NDC:68479-202-00 2 in 1 POUCH

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2013-06-03


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