Label: GOLD MOUNTAIN BEAUTY INTENSIVE REPAIR SERUM- tolnaftate antifungal lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76348-418-01, 76348-418-02 - Packager: Renu Laboratories, 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 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Acetylated Lanolin Alcohol, Benzoic Acid, Cetyl Acetate, Cyclopentasiloane,
Deionized Water, Dimethicone Copolyl, Dimethiconol, Ethoxydiglycol, Glycerin,
Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil,
Hydroxyethylacrylate/Sodium Acryloyldimethyl Taurate copolymer, Menthol (and) Menthyl Lactate,
Olea Europaea (Olive) Oil, Phenoxyethanol, Phenyl Trimethicone, Polysorbate 60, Polysorbate 80,
Propylene Glycol, Squalane, Talc.
- QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
- GOLD MOUNTAIN Beauty FOOT THERAPY INTENSE HYDRATION INTENSIVE REPAIR SERUM
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INGREDIENTS AND APPEARANCE
GOLD MOUNTAIN BEAUTY INTENSIVE REPAIR SERUM
tolnaftate antifungal lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-418 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 2.8 g in 28 g Inactive Ingredients Ingredient Name Strength CETYL ACETATE (UNII: 4Q43814HXS) 2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C) POLYSORBATE 60 (UNII: CAL22UVI4M) BENZOIC ACID (UNII: 8SKN0B0MIM) TALC (UNII: 7SEV7J4R1U) HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J) CYCLOMETHICONE (UNII: NMQ347994Z) POLYSORBATE 80 (UNII: 6OZP39ZG8H) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) OLIVE OIL (UNII: 6UYK2W1W1E) SQUALANE (UNII: GW89575KF9) DEHYDROACETIC ACID (UNII: 2KAG279R6R) HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741) MENTHOL (UNII: L7T10EIP3A) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-418-02 1 in 1 BOX 07/02/2018 1 NDC:76348-418-01 28 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/02/2018 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-418)