Label: ARNICA DE LA ABUELA- heterotheca inuloides cass, wintergreen, balsam of peru ointment
- NDC Code(s): 60854-001-01, 60854-001-02
- Packager: LABORATORIOS BREMER, S.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 30, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ARNICA DE LA ABUELA
heterotheca inuloides cass, wintergreen, balsam of peru ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60854-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68) (HETEROTHECA INULOIDES FLOWER - UNII:W9NZ9OZF68) HETEROTHECA INULOIDES FLOWER 0.59 g in 104 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 1.48 g in 104 mL BALSAM PERU (UNII: 8P5F881OCY) (BALSAM PERU - UNII:8P5F881OCY) BALSAM PERU 0.88 g in 104 mL Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) PARAFFIN (UNII: I9O0E3H2ZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60854-001-01 44 mL in 1 CAN; Type 0: Not a Combination Product 01/01/2016 2 NDC:60854-001-02 31 mL in 1 CAN; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 01/01/2016 Labeler - LABORATORIOS BREMER, S.A. (811585264) Establishment Name Address ID/FEI Business Operations LABORATORIOS BREMER, S.A. 811585264 manufacture(60854-001)