Label: EARWAX REMOVAL DROPS EQUATE- carbamide peroxide 6.5% liquid
- 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 December 29, 2017
If you are a consumer or patient please visit this version.
- Active ingredient Purpose
- INDICATIONS & USAGE
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 consecutive
days; if excessive earwax remains after use of this
product, consult a doctor
When using this product • avoid contact with eyes.
If accidental contact with eyes occurs, flush eyes
with water and consult a doctor
DOSAGE & ADMINISTRATION
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 the 4-day treatment may be removed
by gently flushing the ear with warm water, using a
soft rubber bulb ear syringe.
Children under 12 years of age: consult a doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EARWAX REMOVAL DROPS EQUATE
carbamide peroxide 6.5% liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-537 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 6.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) SODIUM STANNATE (UNII: NJ7C1V83KG) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-537-01 1 in 1 CARTON 06/05/2017 1 15 mL in 1 BOTTLE; 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 06/05/2017 Labeler - Walmart (051957769) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(49035-537) , label(49035-537)