Label: AURALYT- carbamide peroxide liquid
- NDC Code(s): 53145-311-04
- Packager: Menper Distributors, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 3, 2020
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- Active Ingredient
AVOID CONTACT WITH EYES
Do not use :
- if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy, consult a doctor
- if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor
- for more than 4 days; if excessive ear wax remains after use of this product, consult a doctor.
- KEEP OUT OF REACH OF CHILDREN
- if pregnate or breast-feeding
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 the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using soft ruber bulb ear syringe.
- Children under 12 years of age: consult a doctor.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
carbamide peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-311 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 7.8 mg in 12 mL Inactive Ingredients Ingredient Name Strength CAJUPUT OIL (UNII: J3TO6BUQ37) CAMPHOR (NATURAL) (UNII: N20HL7Q941) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) PHOSPHORIC ACID (UNII: E4GA8884NN) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STANNATE (UNII: NJ7C1V83KG) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53145-311-04 1 in 1 CARTON 01/01/2014 1 12 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 01/01/2014 Labeler - Menper Distributors, Inc (101947166)