Label: ACNECARE DERMACONTROL CREAM- salicylic acid liquid
- NDC Code(s): 68062-8090-1
- Packager: Spa de Soleil
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 December 23, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
If swallowed, get medical help or contact a Poison Control Center right away. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Keep out of reach of children.
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
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DOSAGE & ADMINISTRATION
Directions:
Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and consult a doctor.
Sensitivity test for a new user: Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the directions as stated.
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INACTIVE INGREDIENT
Other Ingredients:
Aqua, Caprylic/Capric Triglyceride, Cetyl Alcohol, Ethoxydiglycol, Polyglyceryl-6 Distearate, Stearic Acid, Dimethicone, Jojoba Esters, Carbomer, Lactic Acid, Glycolic Acid, Hydroxyethylcellulose, Sodium Hydroxide, Polyglyceryl-3 Beeswax, Sodium PCA, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, BHT, Titanium Dioxide, *CO Glycerin, Glycerin, Citric Acid, Malic Acid, DMAE, Ubiquinone, Thioctic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Salicylic Acid, Tartaric Acid, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Dehydroacetic Acid. *Certified Organic
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNECARE DERMACONTROL CREAM
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68062-8090 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 3 mg in 60 mL Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) ETHOXYDIGLYCOL OLEATE (UNII: 843B4EZH9X) CAPRYLIC/CAPRIC ACID (UNII: DI775RT244) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68062-8090-1 60 mL in 1 TUBE; Type 0: Not a Combination Product 12/23/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 12/23/2022 Labeler - Spa de Soleil (874682867) Registrant - Spa de Soleil (874682867) Establishment Name Address ID/FEI Business Operations Spa de Soleil 874682867 manufacture(68062-8090)