PHARMBANNER TINEA VERSICOLOR CREAM- tinea versicolor cream cream

PHARMBANNER TINEA VERSICOLOR Cream by

Drug Labeling and Warnings

PHARMBANNER TINEA VERSICOLOR Cream by is a Otc medication manufactured, distributed, or labeled by Shenzhen Xinxin Yunhai Technology Co., Ltd., Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Use

Cures most athlete’s foot (tinea pedis)
Cures most jock itch (tinea cruris) and ringworm (tinea corporis)
Relieves itching, burning, cracking and scaling which accompany these conditions
Also helps relieve symptoms of tinea versicolor (pityriasis versicolor)

Warnings

For external use only.

Do not use

On nails or scalp
In or near the mouth or eyes
For vaginal yeast infections

When Using

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop Use

Irritation occurs or gets worse
Symptoms do not improve after 4 weeks

Ask Doctor

Irritation occurs or gets worse
Symptoms do not improve after 4 weeks

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and children 12 years and older:
- Wash the affected area with soap and water and dry completely before applying.
- Apply a thin layer to affected skin once or twice daily as directed.
- For tinea versicolor: apply once daily for 2 weeks.
- Wash hands after each use.
Children under 12 years: ask a doctor.

Other information

Store at controlled room temperature 20°–25 °C (68°–77 °F).
Do not use if the seal is broken.

Inactive ingredients

Purified Water (Aqua), Cetyl Alcohol, Stearyl Alcohol, Cetyl Palmitate, Isopropyl Myristate, Polysorbate 60, Sorbitan Monostearate, Benzyl Alcohol, Sodium Hydroxide, Panthenol(1%), Urea(4%), Menthol(0.5%)

Questions

Email: cs@pharmbanners.com
Website: pharmbanners.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHARMBANNER TINEA VERSICOLOR CREAM 
tinea versicolor cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83818-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)	TERBINAFINE HYDROCHLORIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PANTHENOL (UNII: WV9CM0O67Z)
UREA (UNII: 8W8T17847W)
MENTHOL (UNII: L7T10EIP3A)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83818-024-01	60 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/01/2025

Labeler - Shenzhen Xinxin Yunhai Technology Co., Ltd. (699816806)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(83818-024)