Tricylate™

Tricylate™
SPL v5
SPL
SPL Set ID 4869b63a-e01e-4a79-a493-7a1b4d3e914b
Route
TOPICAL
Published
Effective Date 2024-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (20 mg) Salicylic Acid (100 mg)
Inactive Ingredients
Alkyl (c12-15) Benzoate Butylparaben Papaya Safflower Oil Cetyl Alcohol Dimethicone, Unspecified Edetate Disodium Ethylparaben Glycerin Glyceryl Monostearate Peg-100 Monostearate Hydrogenated Polydecene Type I Hydroxyethyl Cellulose, Unspecified Isobutylparaben Methylparaben Phenoxyethanol Propylene Glycol Propylparaben Water Sodium Lactate Sodium Polyacrylate (2500000 Mw) Trideceth-6 Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-17

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

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.

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
Menthol 2% Topical Analgesic
Methyl Salicylate 10% Topical Analgesic
Warnings

For external use only

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.
Do Not Use
  • Do not use otherwise than as directed.
Other Information

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

Questions/comments?

(210) 944-6920

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.

When Using This Product
  • Avoid contact with eyes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
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)


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Menthol 2% Topical Analgesic
Methyl Salicylate 10% Topical Analgesic
Warnings

For external use only

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.
Do Not Use (Do not use)
  • Do not use otherwise than as directed.
Other Information (Other information)

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

Questions/comments? (Questions/Comments?)

(210) 944-6920

Inactive Ingredients (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.

When Using This Product (When using this product)
  • Avoid contact with eyes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
Principal Display Panel 85 G Pouch Tube Label (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)


Advanced Ingredient Data


Raw Label Data

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