OTOFLAM  HP- belladonna , conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla, silicea, chamonilla liquid 
Apotheca, Company

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.

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Otoflam HP

ACTIVE INGREDIENTS:  Belladonna 30X, Conium maculatum 30X, Dulcamara 30X, Ferrum phosphoricum 30X, Hepar sulphuris calcareum 30X, Kali bichromicum 30X, Mercurius solubilis 30X, Pulsatilla 30X, Silicea 30X, Chamomilla 30C.

INDICATIONS:  For temporary relief of symptoms due to inflammation and pain of ears.

WARNINGS:  If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.  Do not use if tamper evident seal is broken or missing.  Store in a cool, dry place.


Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

SUGGESTED USE:  Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional.  If symptoms persist, consult your health care professional.  Consult a physician for use in children under 12 years of age.

INDICATIONS: For temporary relief of symptoms due to inflammation and pain of ears.

INACTIVE INGREDIENTS:  Demineralized water, 20% Ethanol



Dist. By:

Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078


ENERGIQUE

OTOFLAM HP

Homeopathic Remedy

1 fl. oz. (30 ml)

Otoflam HP

Otoflam HP

OTOFLAM   HP
belladonna , conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla, silicea, chamonilla liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0371
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_X]  in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP30 [hp_X]  in 1 mL
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP30 [hp_X]  in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE30 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE30 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS30 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57520-0371-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/08/201009/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/08/201009/09/2022
Labeler - Apotheca, Company (844330915)
Registrant - Apotheca, Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(57520-0371) , api manufacture(57520-0371) , label(57520-0371) , pack(57520-0371)

Revised: 4/2022
 
Apotheca, Company