PEDIATRIC EARACHE REMEDY- ear drops 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.

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Pediatric Earache Remedy

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

Label

Carton

PEDIATRIC EARACHE REMEDY 
ear drops liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-050
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 1 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE3 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR3 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GRAPEFRUIT (UNII: O82C39RR8C)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64616-050-021 in 1 CARTON07/30/2007
1NDC:64616-050-0115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/23/2006
Labeler - Vitality Works, Inc (137752817)
Registrant - Vitality Works, Inc. (137752817)
Establishment
NameAddressID/FEIBusiness Operations
Vitality Works, Inc.137752817manufacture(64616-050)

Revised: 12/2020
 
Vitality Works, Inc