Rash Relief Clear
FDA Label NDC 15071-704

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 Clear (NDC 15071-704). 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.

Active Ingredients

Dimethicone             20%       

Petrolatum               25%


Purpose

Skin Protectant

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

- Change wet and soiled diapers promptly, cleanse the diaper 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, with each diaper change, and especially at bedtime or anytime exposure to we diapers is prolonged.

Inactive Ingredients

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

Indications & Usage

Uses: Protects minor skin irritation due to diaper rash and helps seal out wetness.

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

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