PUTRIZEN- undecylenic acid, tolnaftate solution

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient(s)

• Undecylenic Acid 25%
• Tolnaftate 1%

Purpose(s)

• Antifungal
• Antifungal

Uses

• cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) ​
• relieves itching, burning. cracking, and scaling which accompany these conditions

Warnings

For external use only

Flammable: keep away from heat and flame

Do not use

• On children under 2 years of age unless directed by a doctor

When using this product

• avoid contact with eyes
• use only as directed
• do not use on broken or irritated skin unless directed by a doctor
• do not bandage tightly

Stop use and ask a doctor if

• irritation occurs or gets worse
• there is no improvement within 4 weeks

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• clean the affected area and dry thoroughly
• apply a thin layer to the affected area twice daily (morning and night) or as directed by a doctor
• for athlete's foot pay special attention to spaces between the toes, wearwell-fitting, venulated shoes, and change shoes and socks at least once dally
• for best results, use daily for at least 4 weeks

Other information

• store at 20° to 25°C (68°-77°F)
• keep tightly closed

Inactive ingredients

UREA, TEA TREE OIL, ISOPROPYL ALCOHOL, ALCOHOL DENAT, AQUA, GLYCERIN, MENTHOL, BORNEOL

Questions or comments?

213-396-1046 / MalachiPerez291@gmail.com

Box Front Panel

PUTRIZEN

Nail Repair Pen

Tolnaftate 1%
Undecylenic Acid 25%

NET: 4ML(0.14 FL OZ) X 5

INGREDIENTS AND APPEARANCE

PUTRIZEN 
undecylenic acid, tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87724-5118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	1 g  in 4 g
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.04 g  in 4 g

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)	0.04 g  in 4 g
UREA (UNII: 8W8T17847W)	0.2 g  in 4 g
ALCOHOL (UNII: 3K9958V90M)	0.4 g  in 4 g
AQUA (UNII: 059QF0KO0R)	0.78 g  in 4 g
ISOPROPYL ALCOHOL (UNII: ND2M416302)	1.4 g  in 4 g
GLYCERIN (UNII: PDC6A3C0OX)	0.08 g  in 4 g
MENTHOL (UNII: L7T10EIP3A)	0.04 g  in 4 g
BORNEOL (UNII: M89NIB437X)	0.02 g  in 4 g

Product Characteristics
Color	white (Transparent)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87724-5118-1	5 in 1 BOX	05/25/2026
1		4 g in 1 APPLICATOR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/25/2026

Labeler - Guangzhou Lianbiquan Biological Technology co., Ltd (840565145)

Registrant - Guangzhou Lianbiquan Biological Technology co., Ltd (840565145)