PERFECTHEAL ANTIFUNGAL- clotrimazole 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.

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Drug Facts

Active ingredient
Clotrimazole 1.0%

Purpose
Antifungal

Uses
cures most ringworm (tinea corporis)
relieves
   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 4 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 4 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
Box2.jpg

PERFECTHEAL ANTIFUNGAL 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69070-303
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
STEARETH-20 (UNII: L0Q8IK9E08)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69070-303-011 in 1 BOX12/06/2018
110 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/06/2018
Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(69070-303)

Revised: 5/2019
Document Id: 29610cf1-7f09-436e-8a4b-0422caed4498
Set id: d9750991-8f10-4d6b-8841-bea022d5ad73
Version: 2
Effective Time: 20190521
 
Zhejiang Dingtai Pharmaceutical Co., Ltd