AU KAH CHUEN FUGICAL- calamine and diphenhydramine hydrochlorid 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
Calamine 10%
Diphenhydramine hydrochloride 2%

Purpose
Skin protectant
External analgesic

Uses
For the temporary relief of pain, itching, and rushes due to:
poison ivy
poison oak
poison sumac

Dries the oozing and weeping of:
poison ivy
poison oak
poison sumac

Warnings
For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

conditions worsens
condition does not improve within 7 days
symptoms clear up and occur again within a few days

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: Apply liberally to affected area not more than 3 to 4 times daily.
Children under 2 years: Do not use, consult a doctor

Other information
keep tightly sealed

Inactive ingredients Alcohol, camphor, ceteth-20, cetostearyl alcohol, light mineral oil, menthol, methylparaben, petrolatum, propylparaben, silicon dioxide and water.

Questions or comments? (888) 221-3496 M-F 9am-5pm
you may also report serious side effects to this phone number

Au Kah Chuen Fugical Cream
Calamine 10%
Diphenhydramine hydrochloride 2%
External Analgesic and Poison Ivy, Oak, and Sumac Drying Cream
Net Wt. 0.5 oz (15 g)
NDC 69070-306-01
Unitbox-01.jpg

AU KAH CHUEN FUGICAL 
calamine and diphenhydramine hydrochlorid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69070-306
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.95 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.05 g  in 100 g
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69070-306-011 in 1 BOX06/10/2019
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/10/2019
Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(69070-306)

Revised: 6/2019
Document Id: f2274abd-890a-4140-ae41-ec8c65394b74
Set id: 5b4add17-6c3d-4093-826a-2edb41c1d1db
Version: 1
Effective Time: 20190610
 
Zhejiang Dingtai Pharmaceutical Co., Ltd