FDA Label for Calypxo Hp Pain Relief

View Indications, Usage & Precautions

Calypxo Hp Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Asclemed Usa, Inc. 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.

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Drugs Facts


Active Ingredients



Methyl Salicylate………15.00%

Menthol……………………10.00%


Purpose



Topical Analgesic

Topical Analgesic


Uses



For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.


Warning



  • For external use only.
  • Avoid contact with eyes and mucous membranes.
  • Do not

    • bandage tightly or cover treated areas.
    • use with heating pad.
    • apply to open wounds or damages skin.
      • A mild burning sensation may occur.
      • If severe burning sensation occurs, discontinue use immediately.
      • If symptoms persist for more than seven days, discontinue use and consult physician.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

  • If swallowed, consult physician.
  • If pregnant or breast feeding, contact physician prior to use.

Directions



For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.


Additional Information



Store at room temperature.


Other Ingredients



Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.


Principal Display Panel



NDC 76420-999-01

Calypxo HP

Pain Relief Cream

4 oz (113g)

Distributed by:
Enovachem
PHARMACEUTICALS
Torrance, CA 90501
(310) 320-0100


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