CLEANSER ACNE CLEARING TREATMENT- benzoyl peroxide liquid

Cleanser by

Drug Labeling and Warnings

Cleanser by is a Otc medication manufactured, distributed, or labeled by CarePluss Pharma S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:                      Purpose:
Sulphur 5%...........................................Acne medication

PURPOSE

Uses:For the management of acne

• helps clear up acne blemishes, black heads, helps prevent the development of new acne pimples
• penetrates pores to reduce the number of acne pimples, white heads and black heads
• help keep skin clear of new acne pimples, white heads and black heads
• helps prevent new acne pimples, white heads and black heads from forming
• help prevent the development of new pimples, white heads and black heads

WARNINGS

Warnings: For external use only. When using this product skin irritation and dryness may occur.

Do not use

• if you have sensitive skin and/or are sensitive to Sulphur
• on broken skin
• on skin that ha no breakouts

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
• avoid unnecessary sun exposure and use sun screen, Acne Clearing Moisture with SPL 45
• skin irritation may occur, characterized by redness, burning, itching, peeling, and possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration

Stop use and ask a doctor if

• irritation becomes severe

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If swallowed get medical help or contact a Poison Control center immediately.

INDICATIONS & USAGE

Directions:

• cleanse skin with ACNE CLEARING CLEANSER a benzoyl peroxide acne medication cleansing gel.
• moisten fresh cotton ball with ACNE CLEARING TONIC a salicylic acid serum medication for oil control.
• apply ACNE CLEARING TREATMENT 101 a sulphur and natural anti-inflammatory lotion medication to acne breakout areas.
• start with one application daily then gradually increase to 2 or 3.
• if going outside after cleansing apply sun screen, Acne Clearing Moisture with SPF 45
• if excessive irritation or sensitivity develops stop use of both products and contact a physician.

INACTIVE INGREDIENT

Ingredients: Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben.

DOSAGE & ADMINISTRATION

2 FL OZ / 60 ml

PRINCIPAL DISPLAY PANEL

Treatment 101
Acne Clearing Treatment

INGREDIENTS AND APPEARANCE

CLEANSER  ACNE CLEARING TREATMENT
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51439-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	.006 mg  in .024 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)
ETHYLENE GLYCOL (UNII: FC72KVT52F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
VITAMIN A (UNII: 81G40H8B0T)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
POMEGRANATE (UNII: 56687D1Z4D)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EDETIC ACID (UNII: 9G34HU7RV0)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51439-005-01	.024 mg in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/06/2012

Labeler - CarePluss Pharma S.A. de C.V. (815061551)

Registrant - CarePluss Pharma S.A. de C.V. (815061551)

Establishment
Name	Address	ID/FEI	Business Operations
CarePluss Pharma S.A. de C.V.		815061551	manufacture(51439-005)