Numm Warm Sizzle
FDA Label NDC 61577-4400

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sombra Cosmetics Inc. for the product Numm Warm Sizzle (NDC 61577-4400). 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, keep out of reach of childern, uses, warnings, directions, inactive ingredients, question or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Camphor 3%, Menthol 3%

Purpose

Purpose External Analgesic

Keep Out Of Reach Of Childern

Keep out of reach of childern

Uses

Temporarily relieves minor aches and pains of muscles and joints with: simple backaches,strains, bruises, and sprains

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

aloe barbadensis leaf juice,camellia sinensis (green tea) leaf extract, caprylyl glycol, capsicum annuum fruit extract, carbomer, citrus aurntium dulcis (orange) peel oil, citrus grandis (grapefruit) seed extract, decyl glucoside, filipendula ulmaria flower (queen of the prairie) extract, glycerin, hamamelis virginiana (witch hazel) leaf extract, phenoxyethanol, purified water, rosa damascena flower water, sodium carbornate, yucca schidigera stem extract,

Question Or Comments

1-800-225-3963

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