REXALLEAR RELIEF EAR DROPS- matricaria chamomilla, mercurius solubilis, sulfur solution/ drops

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

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Active ingredient:
Chamomilla 10X, Mercurius solubilis 15X, Sulphur 12X, Sensitivity to drafts, soothing, fullness, sensitivity to cold, itchiness, sensitivity to water
Available from:
Dolgencorp LLC
Administration route:
AURICULAR (OTIC)
Prescription type:
OTC DRUG
Therapeutic indications:
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.
Authorization status:
unapproved homeopathic
Authorization number:
55910-107-07

REXALLEAR RELIEF EAR DROPS- matricaria chamomilla, mercurius solubilis,

sulfur solution/ drops

Dolgencorp LLC

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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RexallEar Relief Ear Drops

Drug Facts

Active ingredients

Chamomilla 10X

Mercurius solubilis 15X

Sulphur 12X

Purpose

Sensitivity to drafts, soothing

fullness, sensitivity to cold

itchiness, sensitivity to water

Uses

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 may occur.

Ask a doctor before use if you have:

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

If pregnant or breast feeding,

ask a health professional before use.

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.

Remove tamper-evident seal from neck of bottle.

Twist cap off bottle.

Tilt head sideways.

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.

Children under 12 years of age consult a doctor.

Other information

Active ingredients are manufactured according to homeopathic principles.

Do not use if tamper-evident safety seal is missing or broken.

Inactive ingredients

Vegetable glycerin

Ques tions ?

1-866-473-9255

Package Labeling:

REXALLEAR RELIEF EAR DROPS

matricaria chamomilla, mercurius solubilis, sulfur solution/ drops

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:559 10 -10 7

Route of Administration

AURICULAR (OTIC)

Dolgencorp LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MATRICARIA CHAMO MILLA (UNII: G0 R4UBI2ZZ) (MATRICARIA CHAMOMILLA -

UNII:G0 R4UBI2ZZ)

MATRICARIA

CHAMOMILLA

10 [hp_X]

in 1 mL

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

UNII:324Y40 38 G2)

MERCURIUS SOLUBILIS

15 [hp_X]

in 1 mL

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

SULFUR

12 [hp_X]

in 1 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:559 10 -10 7-0 7

1 in 1 BOX

0 8 /0 1/20 15

1

12 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 8 /0 1/20 15

Labeler -

Dolgencorp LLC (068331990)

Revised: 9/2019

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