Trilogel™

Trilogel™
SPL v4
SPL
SPL Set ID 22af7d63-6a56-4a38-a95b-0f88410b23cb
Route
TOPICAL
Published
Effective Date 2024-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Edetate Disodium Xanthan Gum Glycerin Hydroxypropyl Cellulose, Unspecified Papaya Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Sodium Lactate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-24

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Uses

For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 50566-9

Stop use and ask a physician if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Section 50567-7

When using this product avoid contact with eyes

Section 50570-1

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Section 53414-9

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

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 physician.
Active Ingredient

Lidocaine HCl, USP 2.8%

Other Information

Store at 20-25°C (68-77°F). Protect from freezing.

Inactive Ingredients

Caprylyl Glycol, Carica Papaya (Papaya) Fruit Extract, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcellulose, Phenoxyethanol, Purified Water, Sodium Lactate, Xanthan Gum.

Questions Or Comments?

(210) 944-6920

Principal Display Panel 57 G Pouch Label

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

NDC: 73352-620-01

TRIFLUENT

PHARMA™

Trilogel™

Lidocaine HCl 2.8%

Topical Analgesic Gel

For the temporary relief of pain associated with minor burns, sunburn,

minor cuts, scrapes, insect bites, and minor skin irritations.

NET WT. 2 OZ. (57 G)


Structured Label Content

Uses

For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 50566-9 (50566-9)

Stop use and ask a physician if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 50570-1 (50570-1)

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Section 53414-9 (53414-9)

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

Purpose

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 physician.
Active Ingredient

Lidocaine HCl, USP 2.8%

Other Information

Store at 20-25°C (68-77°F). Protect from freezing.

Inactive Ingredients

Caprylyl Glycol, Carica Papaya (Papaya) Fruit Extract, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcellulose, Phenoxyethanol, Purified Water, Sodium Lactate, Xanthan Gum.

Questions Or Comments? (Questions or Comments?)

(210) 944-6920

Principal Display Panel 57 G Pouch Label (PRINCIPAL DISPLAY PANEL - 57 G Pouch Label)

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

NDC: 73352-620-01

TRIFLUENT

PHARMA™

Trilogel™

Lidocaine HCl 2.8%

Topical Analgesic Gel

For the temporary relief of pain associated with minor burns, sunburn,

minor cuts, scrapes, insect bites, and minor skin irritations.

NET WT. 2 OZ. (57 G)


Advanced Ingredient Data


Raw Label Data

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