Elixirtripleguard Cream
FDA Label NDC 84546-0007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Elixir Healthcare Usa, Llc. for the product Elixirtripleguard (NDC 84546-0007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each gram), purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Gram)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Principal Display Panel

Active Ingredient (In Each Gram)

Miconazole Nitrate 2%w/w

Purpose

Antifungal

Uses

Uses
• For the treatment and prevention of most:
• Athlete’s foot
• Jock itch
• Ringworm
• Relieves itching, scaling, cracking, and discomfort associated with these conditions

Warnings

For external use only

Do Not Use

on children under 2 years of age unless directed by a doctor

When Using This Product

Avoid contact with eyes

Stop Use And Ask A Doctor If

• condition persists or gets worse
• a rash or other allergic reaction develops

Keep Out Of Reach Of Children

In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions

Directions

Clean the affected area and dry thoroughly • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional • Supervise children in the use of this product.

For athlete's foot:• Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes •Wear well fitting, ventilated shoes • Change socks atleast once daily.

For ringworm:Use daily for 4 weeks. If condition persists, consult a healthcare professional.

For jock itch:Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

This product is not effective on the scalp or nails.

Inactive Ingredients

Caprylic/capric triglyceride, Cetereath-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthum Gum