Pain Reliever
FDA Label NDC 35192-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ca-botana International for the product Pain Reliever (NDC 35192-002). 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 warnings, dosage & administration, inactive ingredient, otc - purpose, otc - active ingredient, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

Warnings:For external use only.Do not use on wounds or damaged skinWhen using this product: use only as directed. Avoid contact with eyes. Do no bandage tightlyStop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days. Store at room temperature. Lot number and expiration date see crimp or see box.

Dosage & Administration

Directions:Adults and children over 12 year. Apply generous amount directly to affected area. Massage into painful area until thoroughly absorbed into skin. Repeat as necessary, but no more that 4 times daily.

Inactive Ingredient

INACTIVE INGREDIENTS:Water. Ethanol. PPG-26 Buteth-26 (and) PEG-40. Hydrogenated Castor Oil. Acrylates/C10-30 alkyl acrylate crosspolymer. Triethanolamine. Glucosamine Sulfate. Methyl Sulfonyl Methane. (MSM). Bromelain. Harpagophytum procumbens (Devil's Claw). Hippocastanaceae aesculus hippocastanum (Horse Chestnut). Rosmarinus officinalis. Aloe barbadenis miller. Chamaemelum nobile. Capsicum annuun Extract. Tilia cordata Extract (Linden flower). Melissa officinalis. Arnica montana. Saliz alba. Eucalyptus globoulus. Tocopheryl acetate. Phenoxyethanol Ethylhexyglycerin. Potassium Sorbate. EDTA. FD and C Green # 3. FD and C Yellow # 10

Otc - Purpose

Uses for temporary relief of minor aches and pains of muscles and joint associated with: simple aches, back aches, arthritis, strains, bruises, sprains.

Otc - Active Ingredient

Menthol 2% Topical analgesic

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

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