Label: AGELOC LUMISPA TREATMENT CLEANSER ACNE- salicylic acid lotion
- NDC Code(s): 62839-1495-1
- Packager: NSE Products, Inc
- 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 January 10, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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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 unless directed by a doctor. If swallowed, get medical help or contact a Poison Control Center right away.
- Directions
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Inactive Ingredients
Water (Aqua), Cetearyl Alcohol, Glycerin, PEG-8 Dimethicone, Cocamidopropyl Betaine, Caprylyl/Capryl Glucoside, Capryl/Capramidopropyl Betaine, Carbomer, Narcissus Tazetta Bulb Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Schizandra Chinensis Fruit Extract, Xanthan Gum, Carnosine, Oryza Sativa (Rice) Extract, Disodium EDTA, Phenoxyethanol, Hydroxyacetophenone, Sodium Hydroxide, Sodium Chloride.
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- PRINCIPAL DISPLAY PANEL - 100 ml Tube Label
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INGREDIENTS AND APPEARANCE
AGELOC LUMISPA TREATMENT CLEANSER ACNE
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1495 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Glycerin (UNII: PDC6A3C0OX) PEG-8 Dimethicone (UNII: GIA7T764OD) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) Capryl/Capramidopropyl Betaine (UNII: 231H3ZT9NE) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) NARCISSUS TAZETTA BULB (UNII: K17762966S) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C) Xanthan Gum (UNII: TTV12P4NEE) Carnosine (UNII: 8HO6PVN24W) RICE GERM (UNII: 7N2B70SFEZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Phenoxyethanol (UNII: HIE492ZZ3T) Sodium Hydroxide (UNII: 55X04QC32I) Sodium Chloride (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1495-1 100 mL in 1 TUBE; Type 0: Not a Combination Product 10/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/01/2017 Labeler - NSE Products, Inc (803486393)