Allure Ice Cold Analgesic
FDA Label NDC 52000-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Allure Ice Cold Analgesic (NDC 52000-004). 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, uses, warnings, other, when using this product, stop use and ask doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol             1.0%

Camphor            0.5%

Purpose

Topical Analgesic

Uses

for the temporary relief  of minor aches and pains in muscles and joints associated with
  • simple backache
  • strains
  • sprains
  • sports injuries
  • arthritis
  • bruises

Warnings

For external use only

Other

Do not use
  • with other topical pain relievers
  • with heating pads or heating devices

When Using This Product

  • do not use in or near eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Use And Ask Doctor If

  • condition worsens
  • symptoms last more than 7 days or clean up and occur again within a few days
  • redness or irritation develops

If Pregnant Or Breast-Feeding,

  • ask a health professional before use

Keep Out Of The Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • clean affected area before applying product
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Inactive Ingredient

Benzyl alcohol, butylated hydroxytoluene, carbopol, colour brillient blue, creasmer RH 40, disodium EDTA, isopropyl alcohol, propylene glycol, purified water and sodium hydroxide

Principal Display Panel

ALLURE ICE COLD GELANALGESIC GEL 8 FL.OZ (226 GRAM)

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