Label: MIST- salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61354-013-01 - Packager: OXYGEN DEVELOPMENT, 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 8, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
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Inactive Ingredients
Water/Aqua, Sodium Benzoate, Sodium Polyacrylate, Caprylyl/Capryl Glucoside, Potassium Sorbate, Eucalyptus Globulus Leaf Oil, Glycerin, Salix Alba (Willow) Bark Extract, Rosa Damascena Flower Extract, Citric Acid, achillea Milefolium Flower Extract, Glucose, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil.
- Primary Package
- Secondary Package
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INGREDIENTS AND APPEARANCE
MIST
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61354-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 mg in 100 mg Inactive Ingredients Ingredient Name Strength LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) WATER (UNII: 059QF0KO0R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) GLYCERIN (UNII: PDC6A3C0OX) SALIX ALBA BARK (UNII: 205MXS71H7) ROSA DAMASCENA FLOWER (UNII: JWB78P295A) ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61354-013-01 1 in 1 CARTON 03/09/2021 1 100 mg in 1 BOTTLE; 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 03/09/2021 Labeler - OXYGEN DEVELOPMENT, LLC (137098492) Establishment Name Address ID/FEI Business Operations OXYGEN DEVELOPMENT, LLC 137098492 manufacture(61354-013)