Tricylate Cream
FDA Label NDC 73352-575

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trifluent Pharma Llc for the product Tricylate (NDC 73352-575). 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, otc - purpose, uses, warnings, do not use, when using this product, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
Menthol 2%Topical Analgesic
Methyl Salicylate 10%Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

Do Not Use

  • Do not use otherwise than as directed.

When Using This Product

  • Avoid contact with eyes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Otc - Stop Use

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Directions

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Do not use; consult a doctor.

Other Information

Store at temperatures less than 30°C (86°F).

Inactive Ingredients

Alkyl (C12-15) benzoate, butylparaben, Carica papaya (papaya) fruit extract, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, dimethicone, disodium EDTA, emulsifying wax, ethylparaben, glycerin, glycerol stearate, hydrogenated polydecene, hydroxyethyl cellulose, isobutylparaben, methylparaben, PEG 100 stearate, phenoxyethanol, propylene glycol, propylparaben, purified water, sodium lactate, sodium polyacrylate, trideceth-6, xanthan gum.

Questions/Comments?

(210) 944-6920

Principal Display Panel - 85 G Pouch Tube Label

Tear at notch to open. Do not use if seal is broken.

NDC 73352-575-04

TRIFLUENT
PHARMA™

Tricylate™

2% Menthol
10% Methyl Salicylate

Topical Analgesic Cream

NET WT. 3 OZ. (85 G)

Principal Display Panel (85 G Pouch Tube Label)

Principal Display Panel (85 G Pouch Tube Label)

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