TARGETED ACNE SPOT TREATMENT CVS- benzoyl peroxide 2.50% lotion

Targeted Acne Spot Treatment by

Drug Labeling and Warnings

Targeted Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by CVS, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl peroxide 2.5%

Purpose

Acne Treatment

Uses

Treats and helps prevent new acne blemishes.

Warnings

For external use only.

Do not use if you have

very sensitive skin or if you are sensitive to benzoyl peroxide.

Stop use and ask a doctor if

irritation becomes severe and continues.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison COntrol Center right away.

When using this product

• avoid unnecessary sun exposure and use a sunscreen
• using other topical acne drugs at the same time or right after use may increase dryness or irritation of skin. If this occurs, only one drug should be used.
• keep away from eyes, lips, mouth
• this product may bleach hair or dyed fabrics

Directions

Cleanse skin thoroughly before applying. COver entire affected area with a thin layer 1 to 3 times daily. Start with one application daily, because excessive drying may occur. Then gradually increase to 2 to 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 outsie use a sunscreen. Allow acne medication to dry before application of sunscreen. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

• Keep tightly closed
• Avoid storing at extreme temperatures (below 40 F and above 100 F).

Inactive ingredients

Water, Bentonite, Caprylic/Capric Triglyceride, Glycerin, Emulsifying Wax NF, Polysorbate 20, Glyceryl Laurate, Cetyl Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Sodium Citrate, Disodium EDTA, Citric Acid, Methylparaben, Propylparaben.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TARGETED ACNE SPOT TREATMENT  CVS
benzoyl peroxide 2.50% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.50 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENTONITE (UNII: A3N5ZCN45C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERYL LAURATE (UNII: Y98611C087)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-181-01	1 in 1 CARTON	11/26/2014
1		21 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/26/2014

Labeler - CVS (062312574)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(69842-181) , label(69842-181)