BENZOYL PEROXIDE - benzoyl peroxide 
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

Purifying Cleanser

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

Purifying Cleanser

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

Use for the management of acne

Purifying Cleanser Warning Section

Warnings

For external use only

Do not use this medication if you have very sensitive
skin or if you are very 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 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
- aviod unnecessary sun exposure and use a
sunscreen

Stop use and ask a doctor if skin irritation occurs.

Keep out of the reach of children. If swallowed, get
medical help or contact a Poison Control Center right
away.

Purifying Cleanser Directions Section

Directions

- Use morning and night. Apply a small (dime sized)
amount to dampened skin and gently massage for
1 to 2 minutes.
- Rinse thoroughly with warm water
- Pat dry
- If bothersome dryness 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)

Purifying Cleanser Warning Section

Warnings

For external use only

Do not use this medication if you have very sensitive
skin or if you are very 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 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
- aviod unnecessary sun exposure and use a
sunscreen

Stop use and ask a doctor if skin irritation occurs.

Keep out of the reach of children. If swallowed, get
medical help or contact a Poison Control Center right
away.

Purifying Cleanser Directions Section

Directions

- Use morning and night. Apply a small (dime sized)
amount to dampened skin and gently massage for
1 to 2 minutes.
- Rinse thoroughly with warm water
- Pat dry
- If bothersome dryness 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)



Purifying Cleanser inactive ingredients section

Inactive Ingredients
purified water, disodium PEG-12 dimethicone
sulfosuccinate, magnesium aluminum silicate,
gyyceryl stearate, tridecyl stearate, neopentyl
glycol dicaprylate/dicaprate, tridecyl trimelliate,
PEG-100 Stearate, sorbitol, dimethyl isosorbide,
polyethylene, cetyl esters, anthemis nobilis flower
extract, xanthan gum, propylene glycol,
imidazolidinyl urea, sodium hyaluronate, sodium
PCA, methylparaben, propylparaben, fragrance

front panel

drugfacts

Carton Side


Repairing Lotion

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


Repairing Lotion

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

Use for the management of acne

Repairing Lotion Warning Section

Warnings

For external use only

Do not use this medication if you have very sensitive
skin or if you are very 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 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
- aviod unnecessary sun exposure and use a
sunscreen

Stop use and ask a doctor if skin irritation occurs.

Keep out of the reach of children. If swallowed, get
medical help or contact a Poison Control Center right
away.

Repairing Lotion Directions Section

Directions

- Cleanse the skin thoroughly before applying
medication
- Cover the entire affected area with a thin layer 1 to
3 times daily
- Because excessive drying of the skin may occur,
start with 1 application daily, then gradually
increase to 2 or 3 times daily, if needed or as
directed by a doctor. If bothersome dryness 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)

Repairing Lotion Warning Section

Warnings

For external use only

Do not use this medication if you have very sensitive
skin or if you are very 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 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
- aviod unnecessary sun exposure and use a
sunscreen

Stop use and ask a doctor if skin irritation occurs.

Keep out of the reach of children. If swallowed, get
medical help or contact a Poison Control Center right
away.

Repairing Lotion Directions Section

Directions

- Cleanse the skin thoroughly before applying
medication
- Cover the entire affected area with a thin layer 1 to
3 times daily
- Because excessive drying of the skin may occur,
start with 1 application daily, then gradually
increase to 2 or 3 times daily, if needed or as
directed by a doctor. If bothersome dryness 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)

Repairing Lotion inactive ingredients section

Inactive ingredients
purified water, cetearyl alcohol, ceteareth-20,
ethoxydiglycol, cyclotetrasiloxane, propylene
glycol, dimethicone, glyceryl stearate,
cyclopentasiloxane diazolidinyl urea, methylparaben,
propylparaben, PEG-100 stearate, panthenol,
allantoin, triethanolamine, carbomer, fragrance,
xanthan gum
 
BENZOYL PEROXIDE 
benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-021
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-021-131 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 120 mL
Part 21 BOTTLE, PLASTIC 60 mL
Part 1 of 2
BENZOYL PEROXIDE 
benzoyl peroxide cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE36.9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
PEG-12 STEARATE (UNII: 9KU38O8CEK)  
SORBITOL (UNII: 506T60A25R)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL (UNII: QI80HXD6S5)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
XANTHAN GUM (UNII: TTV12P4NEE)  
IMIDUREA (UNII: M629807ATL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D02/26/2010
Part 2 of 2
BENZOYL PEROXIDE 
benzoyl peroxide lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE36.9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
160 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D02/26/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D02/26/2010
Labeler - Wal-Mart Stores Inc (051957769)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: 4d9de360-92c8-4d41-bb59-7d62656396dc
Set id: bafc44bf-4e1f-4729-a96e-828dc2875486
Version: 10
Effective Time: 20110204
 
Wal-Mart Stores Inc