Rash Relief
FDA Label NDC 15071-604

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 (NDC 15071-604). 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Dimethicone             20%       

Zinc Oxide               25%


Purpose

Skin Protectant


Uses: Treats and prevents minor skin irritation - itching - diaper rash - feeding tubes sites, or lacerations.

Warnings

- Do not use over deep or puncture wounds, infections, or lacerations.  For external use only.

- When using this product do not get into eyes.  If contact occurs, rinse eyes throughout with water.

- Stop use and ask a doctor if condition worsens or does not improve with 7 days.

Directions

- Cleanse skin area, and allow to dry.

- Shake bottle well before use.

- Spray 4-6 inches from skin.  No rub-in is required.

- Apply liberally as often as necessary- each diaper change with incontinence care- to soothe and protect irritated skin.

Inactive Ingredients

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

Indications & Usage

Uses: Treats and prevents minor skin irritation - itching - diaper rash - feeding tubes sites, or lacerations.

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.

* Please review the disclaimer below.