Pediatric Earache Remedy: Homeopathic Product Information

PEDIATRIC EARACHE REMEDY- aconitum napellus, atropa belladonna, potassium chloride, plantago major, matricaria recutita and verbascum thapsus liquid
Vitality Works, Inc

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.

Pediatric Earache Remedy

Aconitum napellus 6X

Belladonna 3X

Chamonilla 6X

Kali mur 3X

Plantago major 3X

Verbascum 6X

Pediatric Earache Remedy

Grapefruit Seed Extract, Olive Leaf Extract, USP Purified Water

Pediatric Earache Remedy

Keep this and all medicines out of reach of children. Before use with children under 3 years of age, or if you are pregnant or nursing, seek the advice of you health care professional. Avoid contact with eyes. If symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but they are not intended for internal use.

Pediatric Earache Remedy

Keep this and all medicines out reach of children.

Pediatric Earache Remedy

A homeopathic combination for the temporary relief of earaches, inflammation of external and internal ear. For the temporary relief of earaches from congestion or swelling of middle ear or eustacian tubes.

Pediatric Earache Remedy

Warm up bottle by gently rolling it between your hands before use. Tilt head sideways and place 2 to 3 drops into ear. Tip of applicator should not enter ear canal. Repeat 2-3 times/day for up to 4 days, if needed, or as directed by your health care professional.

Pediatric Earache Remedy

Aconitum napellus — relieves earach, hot, painful, swollen ear.

Belladonna — relieves otitis media, throbbing deep ear pain.

Chamomilla — relieves earache, soreness, swelling, otalgia.

Kali mur — relieves chronic catarrahal conditions of middle ear.

Plantago major — relieves earache, neuralgic earache, otalgia

Verbascum — Relieves catarrhs, otalgia with sense of obstruction.

Pediatric Earache Remedy

PEDIATRIC EARACHE REMEDY ear drops liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64616-050 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 6 [hp_X] in 1 mL ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 3 [hp_X] in 1 mL POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 3 [hp_X] in 1 mL PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 3 [hp_X] in 1 mL MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 6 [hp_X] in 1 mL VERBASCUM THAPSUS (VERBASCUM THAPSUS) VERBASCUM THAPSUS 6 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength GRAPEFRUIT OLEA EUROPAEA LEAF WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64616-050-02 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER (64616-050-01) 1 NDC:64616-050-01 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (64616-050-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/23/2006

Labeler — Vitality Works, Inc (137752817)

Registrant — Vitality Works, Inc. (137752817)

Establishment
Name	Address	ID/FEI	Operations
Vitality Works, Inc.		137752817	manufacture (64616-050)

Revised: 12/2020 Vitality Works, Inc