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  5. Label Information: Dg Health Earwax Removal Kit

FDA Label for Dg Health Earwax Removal Kit

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. STOP USE AND ASK A DOCTOR IF
    6. WHEN USING THIS PRODUCT
    7. KEEP OUT OF THE REACH OF CHILDREN
    8. DIRECTIONS FOR USE IN THE EAR ONLY
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS:
    11. PRINCIPAL DISPLAY PANEL -BOTTLE LABEL 0.5 FL OZ
    12. PRINCIPAL DISPLAY PANEL- CARTON LABEL 0.5 FLOZ

Dg Health Earwax Removal Kit Product Label

The following document was submitted to the FDA by the labeler of this product Dollar General Corporation. 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.

Active Ingredient



Carbamide peroxide, 6.5%


Purpose



Ear wax Remover


Uses



For occasional use as an aid to soften, loosen and remove excessive ear wax.

Warnings



Ask a Doctor before use if you have
  • eardrainage, discharge, ear pain,irritation
  • rash in the ear,or are dizzy
  • injury or perforation (hole) of the ear drum
  • Recently had ear surgery

Stop Use And Ask A Doctor If



  • you need to use for more than 4 days
  • execessive ear wax remain after use of this product

When Using This Product



  • do not use for more than four days
  • avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
  • if excessive earwax remains after the use of this product, consult a doctor

Keep Out Of The Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
  • When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.
  • Children under 12 years: consult a doctor.

Other Information



  • Protect from heat and direct sunlight
  • product foams on contact with ear wax due ot releae of oxygen, there may be associated cracking
  • Keep cap on bottle when not in use.
  • Lot No. and EXP date: see label, bottom container or box.

Inactive Ingredients:



Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid


Principal Display Panel -Bottle Label 0.5 Fl Oz



DG Health

Ear Wax Removal Kit

Carbamide Peroxide 6.5%

0.5 FLOZ (15mL)


Principal Display Panel- Carton Label 0.5 Floz



DG Health

Ear Wax Removal Kit

Carbamide Peroxide 6.5%

0.5 FLOZ (15mL)



* Please review the disclaimer below.