JIDESHENG - clotrimazole gel 
Nantong Jidesheng Biology Health Care Products 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.

----------

JiDeSheng

Active ingredient                             Purpose
Clotrimazole 1%                              Antifungal

Uses
- cure most jock itch
- relieve itching, burning, scaling, chafing and discomfort which accompany this condition.

Warnings - For external use only
- do not use on children under 2 years of age unless directed by a doctor.
- when use this product avoid contact with eyes
- stop use and ask a doctor if irritation occurs or there is no improvement in 2 weeks
- Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Direction
- Wash the affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- supervise children in the use of this product
- use daily for 2 weeks
- if condition persist longer, ask a doctor
- this product is not effective on the scalp or nails

Storage: Store at 20-15 C (68-77 F)

Inactive ingredients:
Water, stearic acid, mineral, glyceryl monostearate, cetostearyl alcohol, menthol, sodium lauryl sulfate, ethyl paraben

stop use and ask a doctor if irritation occurs or there is no improvement in 2 weeks

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

do not use on children under 2 years of age unless directed by a doctor.

Antifungal

                JiDeSheng Anti-Itching Ointment
                                 ANTIFUNGAL
Uses to relieve itching, burning, scaling, chafing and discomfort which accompany this condition.
                        For external use only
                        Product of China
                        Net wt. 1 oz. (30g)

JiDeSheng Label


JIDESHENG 
clotrimazole gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51849-3574
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Mineral oil (UNII: T5L8T28FGP)  
Stearic acid (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
Menthol (UNII: L7T10EIP3A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Ethylparaben (UNII: 14255EXE39)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51849-3574-71 in 1 BOX
129 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/23/2010
Labeler - Nantong Jidesheng Biology Health Care Products Co., Ltd. (545864816)

Revised: 3/2011
Document Id: b75c2d62-eb35-42f3-ab6d-23051bc9fe77
Set id: 65e59613-d2ea-4c04-89c5-0236f85b6cc5
Version: 1
Effective Time: 20110331
 
Nantong Jidesheng Biology Health Care Products Co., Ltd.