EQUATE REPAIRING- benzoyl peroxide lotion

Equate Repairing by

Drug Labeling and Warnings

Equate Repairing by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Use - for the management of acne

KEEP OUT OF REACH OF CHILDREN

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

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)

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.

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)

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

INGREDIENTS AND APPEARANCE

EQUATE REPAIRING 
benzoyl peroxide lotion

Product 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