PIYANPING ANTIFUNGAL- miconazole nitrate cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)
Available from:
Zhejiang Dingtai Pharmaceutical Co., Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antifungal Uses cures most jock itch (tinea cruris)
 relieves the following symptoms associated with jock itch:    itching    scaling    cracking    burning    discomfort    soreness    irritation    redness Do not use
 on children under 2 years of age unless directed by a doctor Stop use and ask a doctor if
 irritation occurs 
there is no improvement within 2 weeks
Authorization status:
OTC monograph final
Authorization number:
69070-304-01

PIYANPING ANTIFUNGAL- miconazole nitrate cream

Zhejiang Dingtai Pharmaceutical Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient

Miconazole nitrate 2.0%

Purpose

Antifungal

Uses

cures most jock itch (tinea cruris)

relieves the following symptoms associated with jock itch:

itching

scaling

cracking

burning

discomfort

soreness

irritation

redness

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

irritation occurs

there is no improvement within 2 weeks

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

Adults and children 2 years of age or older:

wash the affected area and dry thoroughly

apply a thin layer of the product over the affected area twice daily (morning and night) or as directed

by a doctor

supervise children in the use of this product

use daily for 2 weeks

if condition persists longer, consult a doctor

this product is not effective on the scalp or nails

Children under 2 years: do not use unless directed by a doctor

Other information

keep container tightly closed

store between 15 and 30 C (59 to 86 F)

Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol,

sodium sulfite, steareth-20, stearic acid, and water

Questions or comments? (888) 221-3496 M-F 9am-5pm

you may also report serious side effects to this phone number

PerfectHeal Antifungal

Clotrimazole 1%

Antifungal Cream

Net Wt. 10 g (1/3 oz)

NDC 69070-303-01

PIYANPING ANTIFUNGAL

miconazole nitrate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 0 70 -30 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MICO NAZO LE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0 D7S5M)

MICONAZOLE NITRATE

2 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

ETHYLPARABEN (UNII: 14255EXE39 )

GLYCERIN (UNII: PDC6 A3C0 OX)

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

Zhejiang Dingtai Pharmaceutical Co., Ltd

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM SULFITE (UNII: VTK0 1UQK3G)

STEARETH-2 0 (UNII: L0 Q8 IK9 E0 8 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 0 70 -30 4-0 1

1 in 1 BOX

12/0 6 /20 18

1

10 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

12/0 6 /20 18

Labeler -

Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Zhejiang Dingtai Pharmaceutical Co ., Ltd

420 59 8 724

ma nufa c ture (6 9 0 70 -30 4)

Revised: 5/2019

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