ROYCEDERM TINEA TREATMENT CREAM cream

Roycederm Tinea Treatment Cream by

Drug Labeling and Warnings

Roycederm Tinea Treatment Cream by is a Otc medication manufactured, distributed, or labeled by Shandong Yuyaotang Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Miconazole 2%

Purpose

Antifungal

Use

Help relieve the itching.discoloration, irritation, anddiscomfort with tinea versicolorcorporis, cruris and tinea pedis.

Warnings

for external use only

Do not use

Children unde12 years: ask a doctor

When Using

avoidcontact with eyes.If contact occurs, rinse the eyesthoroughly with water.

Stop Use

if condition worsens or does notimprove after reqular use as directed

Ask Doctor

Ask a doctor before use if youare allergic to ingredients in thisproduct

Keep Oot Of Reach Of Children

Keep out of reach of children. lfswallowed, get medical help orcontact a Poison Control Cente(1-800-222-1222)right away.

Directions

Adult and childrenover 12 years or old. Wash handsbefore and after applying thecream. Apply to affected area atthe first sign of blisters, sores, ortingling sensation. Rub in gentlyand thoroughly. Do not use morethan 3 times daily. Children unde12 years: ask a doctor

Other information

Store atroom temperature and out of directsunlight

Inactive ingredients

Water,ARTEMISIA EXTRACT IFHFI],SOPHORA FLAVESCENS ROOT. CNIDIUM MONNIERI FRUITKOCHIA SCOPARIA POLLEN
DICTAMNUS DASYCARPUSROOT, SMILAX GLABRA WHOLE

Questions

Visit www.roycederm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM TINEA TREATMENT CREAM 
roycederm tinea treatment cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84746-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE (UNII: 7NNO0D7S5M) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SMILAX GLABRA WHOLE (UNII: H51N91QNEB)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
WATER (UNII: 059QF0KO0R)
WORMWOOD (UNII: F84709P2XV)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84746-003-01	57 g in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/19/2024

Labeler - Shandong Yuyaotang Pharmaceutical Co., Ltd (974645696)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Yuyaotang Pharmaceutical Co., Ltd		974645696	manufacture(84746-003)