Reactheat
FDA Label NDC 75963-126

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejuventus for the product Reactheat (NDC 75963-126). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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

Otc - Active Ingredient

Active Ingredients                Purpose

Menthol (5%)                       External Analgesic

Capsicum Annum Extract (0.5)     External Analgesic

Otc - Purpose

Uses

For temporary relief of minor aches and pains of muscles such as: simple backache, lumbago, arthritis, neuralgia, strains, bruises and sprains.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Consult a doctor and discontinue use if condition worsens or persists for more than 7 days.

Warnings

For external use only. When using this product, avoid contact with eyes. Wash hands completely after each use. If swallowed seek medical assistance immediately or contact poison control. If you are pregnant or nursing, seeking the advice of your doctor before using this product.

Dosage & Administration

Directions for use

Apply cream to sore muscles and joints and massage into skin as needed. For adults and children 2 years of age and older apply to affected area no more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

Inactive Ingredient

Water, DImethyl Sulfone, Clove Bud Oil, Peppermint Oil, Eucalyptus Oil, Aloe vera, Ascorbic Acid, Tocopherol, Glycine, Wintergreen Oil, Jojoba Oil, Arnica Montana Flower Extract, Polyarylamide, C13-14 Isoparaffin, Laureth 7, Sodium Hydroxymethylglycinate, glycerol.



Image Of Back Label (Back)

Image Of Back Label (Back)

Package Label.Principal Display Panel

ReactheatReactivating Heat Baume4 fl. oz./ 118.29ml

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