FDA Label for Family Care Earwax Removal
View Indications, Usage & Precautions
Family Care Earwax Removal Product Label
The following document was submitted to the FDA by the labeler of this product United Exchange Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient Purpose
Carbamide peroxide 6.5%.................................Ear wax removal
Otc - Purpose
Uses
For occasional use as an aid to soften, loosen, and remove excessive ear wax.
Warnings
Warnings
Ask a doctor before use if you have
- ear drainage or discharge
- ear pain
- dizziness
- irritation or rash in the ear
- recently had ear surgery
- an injury or perforation (hole) of the eardrum
Otc - Stop Use
Stop use and ask a doctor if
- you need to use for more than four days
- excessive earwax remains after use of this product
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
FOR USE IN THE EAR ONLY
- adults and children over 12 years of age:
- tilt head sideways and place 5 to 10 drops into ear
- tip of applicator should not enter ear canal
- keep drops in ear for several minutes by keeping head tilted or placing cotton in ear
- use twice daily for up to four days if needed, or as directed by a doctor
- any way remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe
- children under 12 years: consult a doctor
Storage And Handling
Other information
- do not store above 25°C (77°F)
- store bottle in the outer carton
- product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound
- keep cap on bottle when not in use
Inactive Ingredient
Inactive ingredients
citric acid monohydrate, flavor, glycerin, propylene glycol, purified water, sodium lauroyl sarcosinate, sodium stannate
Dosage & Administration
Distributed by:
United Exchange Corp.
Cypress, CA 90630
Made in China
Package Label.Principal Display Panel
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