Label: CRYSTAL CLEAR ACNE TREATMENT PADS- salicylic acid patch
- NDC Code(s): 83316-001-01
- Packager: Skin Pharm, LLC
- 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 March 21, 2023
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- Drug Facts
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
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 contact with eyes, lips and mouth. If contact occurs, flush thoroughly with water.
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Directions
• clean the skin thoroughly before applying this product • cover the entire affected area one to two times daily, avoiding eye area • allow to absorb before applying additional products • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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 • do not rinse • tighten cap after use to prevent pads from drying out.
• 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 stated above. -
Other information
• store at 68° - 77° F • protect from excessive moisture
• Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for a week afterwards. -
Inactive ingredients
Allantoin, Aloe (Aloe barbadensis) leaf extract, Beta-glucan, Caprylic/capric triglyceride, Chamomile (Chamomilla recutita) flower extract, Cucumber (Cucumis sativus) fruit extract, Dipotassium glycyrrhizate, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Glycolic acid, Grapefruit (Citrus grandis) peel extract, Lactic acid, Licorice (Glycyrrhiza glabra) root extract, Menthyl lactate, PEG-40 hydrogenated castor oil, Phenoxyethanol, PPG-26-Buteth-26, Sodium hydroxide, Tetrasodium EDTA, Water (Aqua), White mulberry (Morus alba) root extract
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- Packaging
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INGREDIENTS AND APPEARANCE
CRYSTAL CLEAR ACNE TREATMENT PADS
salicylic acid patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83316-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CHAMOMILE (UNII: FGL3685T2X) CUCUMBER (UNII: YY7C30VXJT) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCOLIC ACID (UNII: 0WT12SX38S) CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) PHENOXYETHANOL (UNII: HIE492ZZ3T) PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE SODIUM (UNII: MP1J8420LU) WATER (UNII: 059QF0KO0R) MORUS ALBA ROOT (UNII: CST1G9BZGD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83316-001-01 60 in 1 JAR 02/16/2023 1 1.2 mL in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 02/16/2023 Labeler - Skin Pharm, LLC (040717587)