SKIN PHARMACY ADVANCED ACNE THERAPY TARGETED TREATMENT WIPES- benzoyl peroxide swab

Skin Pharmacy Advanced Acne Therapy by

Drug Labeling and Warnings

Skin Pharmacy Advanced Acne Therapy by is a Otc medication manufactured, distributed, or labeled by AMCOL Health & Beauty Solutions, Inc. DBA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Uses

• for the management of acne

Warnings

For external use only

Do not use if you

• Have very sensitive skin
• Are sensitive to benzoyl peroxide

Ask a doctor of pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product.

When using this product

• Avoid unnecessary sun exposure and use a sunscreen.
• Avoid contact with lips, eyes, or mouth.
• Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling.
• Irritation may be reduced by using the product less frequently or in lower concentration.
• Avoid contact with hair and dyed fabrics, which may be bleached by this product.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the skin thoroughly before applying this product.
• Start with one application daily then gradually increase to 2-3 times daily as needed.
• If going outside apply sunscreen after using this product.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• Avoid storing at extreme temperatures (below 40°F and above 100°F).

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Propanediol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone, Cyclopentasiloxane, Steareth-20, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Xanthan Gum, Cetearyl Alcohol, Bentonite, Citric Acid, Sodium Citrate, Disodium EDTA, Ethylhexylglycerin, Sodium Hydroxide, Allantoin, Chamomilla Recutita (Matricaria) Flower Oil, Panthenol

Microsponge® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling

M050735

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2014 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A. of U.S. and imported components

V-31490

CVS® Quality

Money Back Guarantee

#971012

FP415

M050735

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Targeted Treatment Wipes Label

SKIN+PHARMACY

ADVANCED
ACNE THERAPY

TARGETED TREATMENT WIPES
with Microsponge® Technology

2.5% Benzoyl Peroxide

• effectively kills acne-causing bacteria
• promotes healthier, clearer skin
• fragrance free

DERMATOLOGIST TESTED

exclusively at
CVS/pharmacy

10 pre-moistened wipes ● 3.5 x 3 in (8.9 x 7.6 cm)

M050744

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Targeted Treatment Wipes Carton Label

SKIN+PHARMACY

ADVANCED
ACNE THERAPY

TARGETED TREATMENT WIPES
with Microsponge® Technology

2.5% Benzoyl Peroxide

• effectively kills acne-causing bacteria
• promotes healthier, clearer skin
• fragrance free

DERMATOLOGIST TESTED

exclusively at
CVS/pharmacy

2 packs/10 wipes each ● Total 20 pre-moistened wipes

3.5 x 3 in (8.9 x 7.6 cm)

INGREDIENTS AND APPEARANCE

SKIN PHARMACY ADVANCED ACNE THERAPY   TARGETED TREATMENT WIPES
benzoyl peroxide swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68634-068
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)
medium-chain triglycerides (UNII: C9H2L21V7U)
propanediol (UNII: 5965N8W85T)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
steareth-20 (UNII: L0Q8IK9E08)
cyclomethicone 6 (UNII: XHK3U310BA)
glyceryl monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
phenoxyethanol (UNII: HIE492ZZ3T)
xanthan gum (UNII: TTV12P4NEE)
cetostearyl alcohol (UNII: 2DMT128M1S)
bentonite (UNII: A3N5ZCN45C)
citric acid monohydrate (UNII: 2968PHW8QP)
sodium citrate (UNII: 1Q73Q2JULR)
sodium hydroxide (UNII: 55X04QC32I)
edetate disodium (UNII: 7FLD91C86K)
ethylhexylglycerin (UNII: 147D247K3P)
allantoin (UNII: 344S277G0Z)
chamomile flower oil (UNII: 60F80Z61A9)
panthenol (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68634-068-01	2 in 1 CARTON	05/01/2014
1		10 in 1 PACKET
1		1.4 mL in 1 APPLICATOR; 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	05/01/2014

Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	MANUFACTURE(68634-068) , PACK(68634-068) , LABEL(68634-068) , ANALYSIS(68634-068)