Ice Blue Pain Alleviating Rub
FDA Label NDC 82988-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lemisol Corporation for the product Ice Blue Pain Alleviating Rub (NDC 82988-101). 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 other, active ingredients, purpose, indications & usage, warnings:, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Methyl Salicylate8%

Menthol 5.0%

Camphor 3.0%

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

Indications & Usage

Uses provides temporary relief of minor aches and pains in muscles and joints associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings:

For external use only

Otc - When Using

When using this product use only as directed

  • do not bandage or apply heating pads
  • do not apply to wounds or damaged skin
  • avoid contact with eyes and mucous membranes

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • irritation develops
  • symptoms persist for more than 8 days or clear up and return

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control immediately.

Adults And Children Over 12 Years:

Apply generously to affected area

Massage until gel is completely absorbed by skin. Repeat as necessary

Inactive Ingredients

DMDM Hydantoin, Eucalyptus Globulus Leaf Oil, FD&C Blue No 1, Glycerin, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Purified Water.

Principal Display Panel – 8 Oz Spray Label

Greaseless

SIN GRASA

Rx
Rysell®

ICE
BLUE®
FORTE

  • PAIN ALLEVIATING RUB
  • ALIVIO RÁPIDO DEL DOLOR

    • Analgesic/ Analgésico

    SPRAY

    Net Wt. 4 Oz. (118.2 g)e

    Principal Display Panel – 8 Oz Spray Label (Ice00 0000 01)

    Principal Display Panel – 8 Oz Spray Label (Ice00 0000 01)

Principal Display Panel – 8 Oz Gel Label

Greaseless

SIN GRASA

Rx
Rysell®

ICE
BLUE®

Analgesic/ Analgésico

Gel

  • PAIN ALLEVIATING RUB
  • ALIVIO RÁPIDO DEL DOLOR

    • Net Wt. 8 Oz. (226.7 g)e

    Principal Display Panel – 8 Oz Gel Label (Ice00 0000 02)

    Principal Display Panel – 8 Oz Gel Label (Ice00 0000 02)

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