Label: BREAKOUT CLEARING EMERGENCY SPOT FIX- benzoyl peroxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68479-202-00, 68479-202-02 - Packager: Dermalogica, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 5, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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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.
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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.
- Other information
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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
- PRINCIPAL DISPLAY PANEL - 9 mL Tube Carton
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INGREDIENTS AND APPEARANCE
BREAKOUT CLEARING EMERGENCY SPOT FIX
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Polyethylene Glycol 400 (UNII: B697894SGQ) Green Tea Leaf (UNII: W2ZU1RY8B0) Glycyrrhiza Glabra (UNII: 2788Z9758H) Porphyra Umbilicalis (UNII: 14AN0J70WO) Annickia Chlorantha Bark (UNII: H70115MP4A) Oleanolic Acid (UNII: 6SMK8R7TGJ) Lavandula Angustifolia Flowering Top (UNII: 9YT4B71U8P) Tea Tree Oil (UNII: VIF565UC2G) Filipendula Ulmaria Root (UNII: 997724QNDS) Cetyl Alcohol (UNII: 936JST6JCN) Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW) (UNII: 1DXE3F3OZX) Polysorbate 80 (UNII: 6OZP39ZG8H) Glyceryl Monostearate (UNII: 230OU9XXE4) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Ethylhexylglycerin (UNII: 147D247K3P) Butylene Glycol (UNII: 3XUS85K0RA) Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO) Aminomethylpropanol (UNII: LU49E6626Q) Xanthan Gum (UNII: TTV12P4NEE) Edetate Disodium (UNII: 7FLD91C86K) Phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-202-02 1 in 1 CARTON 1 9 mL in 1 TUBE 2 NDC:68479-202-00 2 mL in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 06/03/2013 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations Cosway 620899877 MANUFACTURE(68479-202) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-202)
