Calypxo Hp Pain Relief Cream
FDA Label NDC 76420-999

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Asclemed Usa, Inc for the product Calypxo Hp Pain Relief (NDC 76420-999). 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, uses, warning, otc - keep out of reach of children, directions, additional information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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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Image Description (Label)

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