trimazole™

trimazole™
SPL v2
SPL
SPL Set ID a3bafc52-1404-4e0b-84c1-e28bffcb091e
Route
topical
Published
Effective Date 2024-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1 g)
Inactive Ingredients
aloe vera leaf aminomethylpropanol medium-chain triglycerides cetyl alcohol edetate disodium glyceryl monostearate hydroxypropyl cellulose, unspecified lavender oil tea tree oil methylparaben peg-100 monostearate polyethylene glycol 400 polysorbate 20 polysorbate 60 propylene glycol propylparaben water stearic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-10

Purpose

Antifungal

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses
  • Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis).
  • Relieves itching, cracking, burning, and scaling, which accompany these conditions.
Purpose

Antifungal

Directions
  • Wash the affected area with soap and water and dry thoroughly.
  • Apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor.
  • Supervise children in the use of this product.
  • For Athlete's Foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • For Athlete's Foot and Ringworm, use daily for 4 weeks; for Jock Itch, use daily for 2 weeks. If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
  • Wash hands after each use.
Other Information

Store at 15-30°C (59-86°F). Avoid excessive heat.

Do not use if product is damaged.

Inactive Ingredients

Aloe barbadensis leaf extract, aminomethyl propanol, caprylic / capric triglyceride, cetyl alcohol, disodium EDTA, glyceryl stearate, hydroxypropylcellulose, Lavandula angustifolia (lavender) oil, Melaleuca alternifolia (tea tree) oil, methylparaben, PEG 100 stearate, polyethylene glycol 400, polysorbate 20, polysorbate 60, propylene glycol, propylparaben, purified water, stearic acid.

Description

Drug Facts

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 doctor if irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot or Ringworm) or within 2 weeks (for Jock Itch).

Section 50567-7

When using this product avoid contact with eyes; rinse immediately with cool tap water if contact occurs.

Section 50569-3

Ask a doctor before use if you are using any other medicines or cleansers on your skin.

Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor

Section 53414-9

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

Active Ingredient

Clotrimazole 1%

Questions/comments?

(210) 944-6920

Principal Display Panel 85 G Tube Pouch Label

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

NDC 73352-570-01

TRIFLUENT

PHARMA™

Trimazole™

1% Clotrimazole

Topical Antifungal Cream

NET WT. 3 OZ. (85 G)


Structured Label Content

Warnings

For external use only

Uses
  • Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis).
  • Relieves itching, cracking, burning, and scaling, which accompany these conditions.
Purpose

Antifungal

Directions
  • Wash the affected area with soap and water and dry thoroughly.
  • Apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor.
  • Supervise children in the use of this product.
  • For Athlete's Foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • For Athlete's Foot and Ringworm, use daily for 4 weeks; for Jock Itch, use daily for 2 weeks. If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
  • Wash hands after each use.
Other Information (Other information)

Store at 15-30°C (59-86°F). Avoid excessive heat.

Do not use if product is damaged.

Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf extract, aminomethyl propanol, caprylic / capric triglyceride, cetyl alcohol, disodium EDTA, glyceryl stearate, hydroxypropylcellulose, Lavandula angustifolia (lavender) oil, Melaleuca alternifolia (tea tree) oil, methylparaben, PEG 100 stearate, polyethylene glycol 400, polysorbate 20, polysorbate 60, propylene glycol, propylparaben, purified water, stearic acid.

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 doctor if irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot or Ringworm) or within 2 weeks (for Jock Itch).

Section 50567-7 (50567-7)

When using this product avoid contact with eyes; rinse immediately with cool tap water if contact occurs.

Section 50569-3 (50569-3)

Ask a doctor before use if you are using any other medicines or cleansers on your skin.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor

Section 53414-9 (53414-9)

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

Active Ingredient (Active ingredient)

Clotrimazole 1%

Questions/comments? (Questions/Comments?)

(210) 944-6920

Principal Display Panel 85 G Tube Pouch Label (PRINCIPAL DISPLAY PANEL - 85 G Tube Pouch Label)

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

NDC 73352-570-01

TRIFLUENT

PHARMA™

Trimazole™

1% Clotrimazole

Topical Antifungal Cream

NET WT. 3 OZ. (85 G)


Advanced Ingredient Data


Raw Label Data

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