AU KAH CHUEN FUGICAL- calamine and diphenhydramine hydrochlorid cream

Au Kah Chuen Fugical by

Drug Labeling and Warnings

Au Kah Chuen Fugical by is a Otc medication manufactured, distributed, or labeled by Zhejiang Dingtai Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Calamine 10%
Diphenhydramine hydrochloride 2%

PURPOSE

Purpose
Skin protectant
External analgesic

INDICATIONS & USAGE

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

Warnings
For external use only

WHEN USING

When using this product

avoid contact with the eyes

STOP USE

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

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information
keep tightly sealed

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

AU KAH CHUEN FUGICAL 
calamine and diphenhydramine hydrochlorid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69070-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.95 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.05 g  in 100 g
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69070-306-01	1 in 1 BOX	06/10/2019
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/10/2019

Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd		420598724	manufacture(69070-306)