Label: KIDS EAR RELIEF- matricaria recutita, mercurius solubilis, anemone patens and sulphur solution
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Contains inactivated NDC Code(s)
NDC Code(s): 59262-273-11 - Packager: Similasan Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated January 29, 2014
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Active ingredient
- Purpose
- Active ingredient
- Purpose
- Active ingredient
- Purpose
- Uses:
- Warnings:
- Ask a doctor before use if the child has:
- Stop use and ask a doctor if:
- Keep out of reach of children.
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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:
- Inactive ingredient:
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIDS EAR RELIEF
matricaria recutita, mercurius solubilis, anemone patens and sulphur solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59262-273 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 10 [hp_X] in 10 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 15 [hp_X] in 10 mL ANEMONE PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD) ANEMONE PATENS 12 [hp_X] in 10 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 10 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59262-273-11 1 in 1 BOX 1 10 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 02/15/2014 Labeler - Similasan Corporation (111566530)
