Otc - Active Ingredient
Active Ingredients Purpose
Menthol 1.9% Counterirritant
Methyl Salicylate 13.7% Counterirritant
Cramergesic
FDA Label NDC 11960-0045
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cramer Products Inc for the product Cramergesic (NDC 11960-0045). 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 otc - active ingredient, uses, warnings, dosage & administration, inactive ingredient, otc - questions, principal display panel, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with strain, sprains, bruises, simple backache, and arthritis. Combined with stretching and calisthenics, Cramergesic assists in the warm-up process, especially in cool, damp weather. For longer-lasting relief and to protect clothing, cover with cloth; hold in place with an elastic wrap.
Warnings
For external use only.Use only as directed. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Do not apply to wounds or damaged skin. Avoid contact with the eyes. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor. Consult a doctor before administering to children, including teenagers, with chicken pox or flu.
Dosage & Administration
Directions
Gently massage into painful area. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor. To apply Cramergesic pack: spread 1/8 " layer of Cramergesic over area, cover with a cloth, and secure with an elastic wrap. Do not bandage tightly.
Other information
This product is intended to and will cause mild skin irritation. Discontinue use if excessive irritation of skin develops. Use with caution on fair skin.
Inactive Ingredient
Inactive Ingredients
Lanolin, Paraffin, Petrolatum
Otc - Questions
Stock No. 034522 Mfd. by Cramer Products, Inc. Gardner, Kansas 66030
QUESTIONS? (800) 345-2231 (M-F 8:00AM-5:00PM CST)
FOR MORE INFORMATION VISIT US AT WWW.CRAMERSPORTSMED.COM
Principal Display Panel
Net wt.2.75 ounces (78g)
PROFESSIONAL STRENGTH
CRAMERGESIC OINTMENT
MILD ANALGESIC OINTMENT
- Relieves minor pain of muscle aches, strains and sprains
- Relaxes tight, aching muscles
- Assists in warm-up
- Warm, penetrating treatment of athletic injuries and minor arthritis
Image Of Carton Label (Cg1)
Otc - Purpose
Purpose
counterirritant
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
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