1. Home
  2. Labeler Index
  3. Ca-botana International
  4. 35192-002
  5. Label Information: Pain Reliever

FDA Label for Pain Reliever

View Indications, Usage & Precautions

Table of Contents

    1. WARNINGS
    2. DOSAGE & ADMINISTRATION
    3. INACTIVE INGREDIENT
    4. OTC - PURPOSE
    5. OTC - ACTIVE INGREDIENT
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. INDICATIONS & USAGE

Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Ca-botana International. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



Enter section text here


* Please review the disclaimer below.