Update-85398-006-01

Update-85398-006-01
SPL v2
SPL
SPL Set ID 3b2c1d7f-32c3-aa3b-e063-6394a90a6267
Route
TOPICAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Terbinafine (1 g)
Inactive Ingredients
Potassium Alum Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Glycerin Glyceryl Stearate Aloe Barbadensis Leaf Juice Dimethicone C12-15 Pareth-7 Allantoin Polysorbate 80 Propylene Glycol Ethylparaben Isohexadecane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-18

Description

Terbinafine Hydrochloride 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea crurs) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions
Dosage and Administration

■ adults and children 12 years and over

■ use the tip of the cap to break the seal and open the tube

■ wash the affected skin with soap and water and dry completely before applying

■ for athlete’s foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.

■ between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor

■ on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor

■ for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor

■ wash hands after each use

■ children under 12 years: ask a doctor

Description

Terbinafine Hydrochloride 1%

Section 50565-1

if swallowed, call a poison control centre or get medical help right away.

Section 50566-9

stop use and ask a doctor if too much irritation occurs or gets worse.

Section 50567-7

do not get into eyes, if eye contact occurs, rinse thoroughly with water.

Section 50570-1
  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections
Section 51727-6

Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Aloe Barbadensis Leaf Juice, Parfum

Section 51945-4

Section 53413-1
Section 55105-1

Antifungal

Section 55106-9

Terbinafine Hydrochloride 1%

Section 60561-8

■ Do not use if seal on tube is broken or is not visible.

■ Store at 68–77°F (20–25°C)


Structured Label Content

Indications and Usage (34067-9)
  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea crurs) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions
Dosage and Administration (34068-7)

■ adults and children 12 years and over

■ use the tip of the cap to break the seal and open the tube

■ wash the affected skin with soap and water and dry completely before applying

■ for athlete’s foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.

■ between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor

■ on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor

■ for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor

■ wash hands after each use

■ children under 12 years: ask a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

if swallowed, call a poison control centre or get medical help right away.

Section 50566-9 (50566-9)

stop use and ask a doctor if too much irritation occurs or gets worse.

Section 50567-7 (50567-7)

do not get into eyes, if eye contact occurs, rinse thoroughly with water.

Section 50570-1 (50570-1)
  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections
Section 51727-6 (51727-6)

Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Aloe Barbadensis Leaf Juice, Parfum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Terbinafine Hydrochloride 1%

Section 60561-8 (60561-8)

■ Do not use if seal on tube is broken or is not visible.

■ Store at 68–77°F (20–25°C)


Advanced Ingredient Data


Raw Label Data

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