Label: TREATMENT 101 ACNE CLEARING TREATMENT- sulphur liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 51439-004-01 - Packager: CarePluss Pharma S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated March 20, 2013
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- ACTIVE INGREDIENT
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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
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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
- 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
- irritation becomes severe
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TREATMENT 101 ACNE CLEARING TREATMENT
sulphur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51439-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR .003 mg in .06 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CATALINA (UNII: T3JI0587Q7) ARNICA MONTANA (UNII: O80TY208ZW) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) CETEARETH-12 (UNII: 7V4MR24V5P) BROMELAINS (UNII: U182GP2CF3) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) MINERAL OIL (UNII: T5L8T28FGP) ETHYLENE GLYCOL (UNII: FC72KVT52F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) TROLAMINE (UNII: 9O3K93S3TK) ASCORBIC ACID (UNII: PQ6CK8PD0R) DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9) PEPPERMINT OIL (UNII: AV092KU4JH) PIPERINE (UNII: U71XL721QK) MINT (UNII: FV98Z8GITP) EDETIC ACID (UNII: 9G34HU7RV0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51439-004-01 .06 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(51439-004)