PUTRIZEN TEA TREE OIL ANTIFUNGAL CREAM- glycerin cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

TEA TREE OIL、UNDECYLENIC ACID、EUCALYPTUS GLOBULUS LEAF、MENTHA PIPERITA LEAF、LICORICE ROOT EXTRACT、ALLANTOIN、PANTHENOL、ALOE VERA LEAF、CHAMOMILE/MATRICARIA、LAVENDER OIL

PURPOSE

Helps prevent most athlete's foot with daily use. For effective relief of itching, burning and cracking.

WHEN USING

1, clean the affected area with soap and water, then dry thoroughly.
2. Apply a thin layer to the affected area twice daily(morning and night).
3. Use daily as part ofyour routine for up to 4 weeks. if the issue persists beyond this time, consult a doctor.

WARNINGS

For external use only."Do not use if seal under cap is broken or missing."Close the lid tightly after use.Do not use this product if you are allergic to any of its ingredients.Do not use on children under 2 years of age unless directed by a doctor. Ask a doctor before use if you have Diabetes.When using this productAvoid contact with the eyes. Stop use and ask a doctor if- Irritation occurs There is no improvement within 4 weeks.If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DO NOT USE

Do not use if seal under cap is broken or missing."Close the lid tightly after use.Do not use this product if you are allergic to any of its ingredients.Do not use on children under 2 years of age unless directed by a doctor.

STOP USE

Stop use and ask a doctor if- Irritation occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

STORAGE AND HANDLING

Store at 200-25°c(68°-77°F) away from direct sunlight and heat

INACTIVE INGREDIENT

WATER、GLYCERIN、MINERAL OIL、GLYCERYL、MONOSTEARATE、1,2-HEXANEDIOL、CARBOMER、HOMOPOLYMER TYPE A、TROLAMINE

INDICATIONS & USAGE

1., clean the affected area with soap and water, then dry thoroughly.
2. Apply a thin layer to the affected area twice daily(morning and night).
3. Use daily as part ofyour routine for up to 4 weeks. if the issue persists beyond this time, consult a doctor.

DOSAGE & ADMINISTRATION

1., clean the affected area with soap and water, then dry thoroughly.
2. Apply a thin layer to the affected area twice daily(morning and night).
3. Use daily as part ofyour routine for up to 4 weeks. if the issue persists beyond this time, consult a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PUTRIZEN TEA TREE OIL ANTIFUNGAL CREAM 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84983-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LICORICE (UNII: 61ZBX54883) (LICORICE - UNII:61ZBX54883)	LICORICE	0.4 mg  in 100 mg
MENTHA PIPERITA LEAF (UNII: A389O33LX6) (MENTHA PIPERITA LEAF - UNII:A389O33LX6)	MENTHA PIPERITA LEAF	0.3 mg  in 100 mg
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.02 mg  in 100 mg
LAVENDER OIL (UNII: ZBP1YXW0H8) (LAVENDER OIL - UNII:ZBP1YXW0H8)	LAVENDER OIL	0.8 mg  in 100 mg
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	2 mg  in 100 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X)	ALOE VERA LEAF	1.5 mg  in 100 mg
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	1.5 mg  in 100 mg
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) (CHAMAEMELUM NOBILE FLOWER - UNII:O2T154T6OG)	CHAMAEMELUM NOBILE FLOWER	0.8 mg  in 100 mg
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.8 mg  in 100 mg
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	0.35 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	2 mg  in 100 mg
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)	0.2 mg  in 100 mg
WATER (UNII: 059QF0KO0R)	77.63 mg  in 100 mg
MINERAL OIL (UNII: T5L8T28FGP)	3 mg  in 100 mg
TROLAMINE (UNII: 9O3K93S3TK)	0.2 mg  in 100 mg
GLYCERIN (UNII: PDC6A3C0OX)	8 mg  in 100 mg
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.5 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84983-030-01	100 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/22/2026

Labeler - Shantou South Moon Biotechnology Co., Ltd. (457126192)

Establishment
Name	Address	ID/FEI	Business Operations
Shantou South Moon Biotechnology Co., Ltd.		457126192	manufacture(84983-030)