Label: OTOFLAM HP (belladonna, conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla- pratensis, silicea, chamomilla. liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 44911-0513-1 - Packager: Energique, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated September 1, 2021
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS AND USAGE:
- INACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
OTOFLAM HP
belladonna, conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla (pratensis), silicea, chamomilla. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0513 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE 30 [hp_X] in 1 mL CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP 30 [hp_X] in 1 mL SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 30 [hp_X] in 1 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 30 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 30 [hp_X] in 1 mL POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 30 [hp_X] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 30 [hp_X] in 1 mL ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS 30 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 30 [hp_X] in 1 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0513-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 10/03/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/03/2019 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0513) , api manufacture(44911-0513) , label(44911-0513) , pack(44911-0513)