EQUATE REPAIRING - benzoyl peroxide lotion 
Wal-Mart Stores Inc

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.

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drug facts



Active ingredient                                     Purpose
Benzoyl Peroxide, 2.5%.......................................Acne Treatment


Use
- for the management of acne


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 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)

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.


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)


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

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EQUATE REPAIRING 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-020-251 in 1 CARTON
160 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D10/10/2011
Labeler - Wal-Mart Stores Inc (051957769)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 4/2012
Document Id: 377a73c8-06c1-4405-9521-21db4e483dde
Set id: 50f3c68a-e854-48c4-8aa9-c80dbb368bb3
Version: 1
Effective Time: 20120426
 
Wal-Mart Stores Inc