Rash Relief Antifungal
FDA Label NDC 15071-804

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Touchless Care Concepts Llc for the product Rash Relief Antifungal (NDC 15071-804). 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 ingredients, purpose, warnings, directions, inactive ingredients, indications & usage, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Miconazole Nitrate      2%

Dimethicone             10%       

Petrolatum               10%


Purpose

Antifungal / Skin Protectant

Warnings

- Ask a doctor before use on children under the age of two.  For external use only.

- When using this product do not get into eyes. 

- Stop use and ask a doctor if: irritation develops; there is no improvement within 4 weeks for athlete's foot or ringworm; or within 2 weeks for jock itch.

Directions

- Clean the affected area and dry thoroughly. 

- Shake bottle well before use.

- Spray 4-6 inches from skin twice daily (morning and night) or as directed by a physician.  No rub-in is required.


Inactive Ingredients

Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, Water, White Petrolatum

Indications & Usage

Uses: Treats jock itch, ringworm, and athlete's foot

Otc - Keep Out Of Reach Of Children

- Keep out of reach of children.  If swallowed, get medical help or contact a local poison control center immediately

Package Label.Principal Display Panel

Rraf (Rraf)

Rraf (Rraf)

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