KIDS EAR RELIEF- matricaria recutita, mercurius solubilis, anemone patens and sulphur solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ), MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2), ANEMONE PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD), SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)
Available from:
Similasan Corporation
Administration route:
AURICULAR (OTIC)
Prescription type:
OTC DRUG
Therapeutic indications:
sensitivity to drafts, soothing fullness, sensitivity to cold night time calmative itchiness, sensitivity to water Helps relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear. - ear drainage or discharge - pain, irritation, or rash in the ear - had ear surgery - dizziness - irritation (too much burning) or pain occurs - symptoms persist for more than 48 hours
Authorization status:
unapproved homeopathic
Authorization number:
59262-273-11

KIDS EAR RELIEF- matricaria recutita, mercurius solubilis, anemone patens and

sulphur solution

Similasan Corporation

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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Kids Ear Relief

Active ingredient

Chamomilla 10X

Purpos e

sensitivity to drafts, soothing

Active ingredient

Mercurius solubilis 15X

Purpos e

fullness, sensitivity to cold

Active ingredient

Pulsatilla 12X

Purpos e

night time calmative

Active ingredient

Sulphur 12X

Purpos e

itchiness, sensitivity to water

Us es :

Helps relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of

water-clogged ears by helping clear water trapped in the ear.

Warnings :

Do not use in the eyes.

Initial exacerbation of symptoms may occur.

Ask a doctor before use if the child has:

ear drainage or discharge

pain, irritation, or rash in the ear

had ear surgery

dizziness

Stop use and ask a doctor if:

irritation (too much burning) or pain occurs

symptoms persist for more than 48 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions :

FOR USE IN THE EAR ONLY.

For children ages 2 and over:

Remove tamper-evident seal from neck of bottle.

Twist cap off bottle.

Tilt child’s head sideways.

Squeeze plastic applicator and apply 4 to 5 drops in each affected ear (applicator should not enter

ear canal).

Keep drops in ear by keeping head tilted or placing cotton in ear.

Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.

Other information:

Active ingredients are manufactured according to homeopathic principles.

Inactive ingredient:

Vegetable glycerin

Ques tions ?

Reach our representatives at 1-800-240-9780 or email us at getinfo@similasanusa.com

www.Similas anUSA.com

PRINCIPAL DISPLAY PANEL

NDC 59262-273-11

Similasan

Kids Ear Relief

EAR DROPS

10 ml / 0.33 fl oz

KIDS EAR RELIEF

matricaria recutita, mercurius solubilis, anemone patens and sulphur solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 26 2-273

Route of Administration

AURICULAR (OTIC)

Similasan Corporation

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MATRICARIA RECUTITA (UNII: G0 R4UBI2ZZ) (MATRICARIA RECUTITA -

UNII:G0 R4UBI2ZZ)

MATRICARIA

RECUTITA

10 [hp_X]

in 10 mL

MERCURIUS SO LUBILIS (UNII: 324Y40 38 G2) (MERCURIUS SOLUBILIS -

UNII:324Y40 38 G2)

MERCURIUS

SOLUBILIS

15 [hp_X]

in 10 mL

ANEMO NE PATENS (UNII: 4M116 9 RWJD) (ANEMONE PATENS - UNII:4M116 9 RWJD)

ANEMONE PATENS

12 [hp_X]

in 10 mL

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

12 [hp_X]

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:59 26 2-

273-11

1 in 1 BOX

1

10 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery

Device/System (syringe, patch, etc.)

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

UNAPPROVED HOMEOPATHIC

0 2/15/20 14

Labeler -

Similasan Corporation (111566530)

Revised: 1/2014

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