Label: IMAGE SKINCARE CLEAR CELL CLARIFYING ACNE SPOT TREATMENT- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79458-002-00, 79458-002-01 - Packager: Natural Technology, 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 17, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Salicylic Acid 2%. Purpose: Acne Treatment
- Purpose: Acne Treatment
- For external use only
- - 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. If contact occurs, flush thoroughly with water.
- If swallowed, get medical help or contact Poison Control Center right away.
- - 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
- 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.
- Store at room temperature.
- Aqua/Water/EAU, Propanediol, Butylene Glycol, Polyacrylate Crosspolymer-6, Glycerin, Dimethyl Isosorbide, Zinc PCA, Sodium Hydroxide, Maris Aqua/Sea Water, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tasmannia Lanceolata Fruit/Leaf Extract, Cinnamomum Cassia Bark Extract, Sanguisorba Officinalis Root Extract, Zingiber Officinale (Ginger) Root Extract, Laminaria Digitata Extract, Phenoxyethanol, Chlorella Vulgaris Extract, Saccharide Isomerate, Cinnamal, Limonene, Ethylhexylglycerin.
- Clear Cell clarifying acne spot treatment
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INGREDIENTS AND APPEARANCE
IMAGE SKINCARE CLEAR CELL CLARIFYING ACNE SPOT TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79458-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 g in 1000 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) TASMANNIA LANCEOLATA LEAF (UNII: H8C2R3TXSF) WATER (UNII: 059QF0KO0R) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) TEA TREE OIL (UNII: VIF565UC2G) TASMANNIA LANCEOLATA FRUIT (UNII: PNT2HDL13Q) CHINESE CINNAMON (UNII: WS4CQ062KM) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GINGER (UNII: C5529G5JPQ) LAMINARIA DIGITATA (UNII: 15E7C67EE8) SACCHARIDE ISOMERATE (UNII: W8K377W98I) CINNAMALDEHYDE (UNII: SR60A3XG0F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PROPANEDIOL (UNII: 5965N8W85T) ZINC PIDOLATE (UNII: C32PQ86DH4) LIMONENE, (+)- (UNII: GFD7C86Q1W) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79458-002-01 1 in 1 BOX 03/17/2022 1 NDC:79458-002-00 14 g in 1 TUBE; 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 03/17/2022 Labeler - Natural Technology, LLC (618561906)
14g. NDC: 79458-002-00