Label: EQUATE REPAIRING- benzoyl peroxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-020-25 - Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
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 April 26, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
- cleanse the skin thoroughly before applying medication.
- cover the entire affected area with a thin film 1-3 times daily
- because excessive drying of the skin may occur, start with 1 application daily and then increase to 2 or 3 times if needed or as directed by a doctor.
- if bothersome drying or peeling occurs, reduce application to once a day or every other day
- if going outside, use a sunscreen
Other Information
- this product may bleach hair or dyed fabrics
- avoid storing at extreme temperatures (below 40 degrees F and above 100 degrees F)
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WARNINGS
Warnings
For external use only.
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following the use of this product.
This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
When using this product
- avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water
- Keep away from lips and mouth
- Avoid unnecessary sun exposure and use a sunscreen
Stop use and ask a doctor if skin irritation occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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DOSAGE & ADMINISTRATION
Directions
- cleanse the skin thoroughly before applying medication.
- cover the entire affected area with a thin film 1-3 times daily
- because excessive drying of the skin may occur, start with 1 application daily and then increase to 2 or 3 times if needed or as directed by a doctor.
- if bothersome drying or peeling occurs, reduce application to once a day or every other day
- if going outside, use a sunscreen
Other Information
- this product may bleach hair or dyed fabrics
- avoid storing at extreme temperatures (below 40 degrees F and above 100 degrees F)
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INACTIVE INGREDIENT
Inactive Ingredients purified water, cetearyl alcohol, ceteraeth-20, ethoxydiglycol, cyclotetrasilozane, propylene glycol, dimethicone,
glyceryl stearate, cyclopentasiloxane, diazolidinyl urea, methylparaben, propylparaben, PEG-100 stearate, panthenol, allantonin, triethanolamine,
carbomer, fragrance, xanthan gum
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EQUATE REPAIRING
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE (UNII: 92RU3N3Y1O) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DEXPANTHENOL (UNII: 1O6C93RI7Z) ALLANTOIN (UNII: 344S277G0Z) XANTHAN GUM (UNII: TTV12P4NEE) CARBOMER HOMOPOLYMER TYPE B/C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-020-25 1 in 1 CARTON 1 60 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333D 10/10/2011 Labeler - Wal-Mart Stores Inc (051957769) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture