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NDC 69070-0306-01 Au Kah Chuen Fugical 2; .05; 9.95 g/100g; g/100g; g/100g Details

Au Kah Chuen Fugical 2; .05; 9.95 g/100g; g/100g; g/100g

Au Kah Chuen Fugical is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Zhejiang Dingtai Pharmaceutical Co., Ltd. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; FERRIC OXIDE RED; ZINC OXIDE.

Product Information

NDC	69070-0306
Product ID	69070-306_f2274abd-890a-4140-ae41-ec8c65394b74
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Au Kah Chuen Fugical
Proprietary Name Suffix	n/a
Non-Proprietary Name	Calamine and Diphenhydramine hydrochlorid
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	2; .05; 9.95
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE; FERRIC OXIDE RED; ZINC OXIDE
Labeler Name	Zhejiang Dingtai Pharmaceutical Co., Ltd
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69070-0306-01 (69070030601)

Pricing Information	N/A
NDC Package Code	69070-306-01
Billing NDC	69070030601
Package	1 TUBE in 1 BOX (69070-306-01) / 15 g in 1 TUBE
Marketing Start Date	2019-06-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5b4add17-6c3d-4093-826a-2edb41c1d1db Details

SPL UNCLASSIFIED SECTION

Active ingredient

Calamine 10%

Diphenhydramine hydrochloride 2%

SPL UNCLASSIFIED SECTION

Purpose

Skin protectant

External analgesic

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Warnings

For external use only

SPL UNCLASSIFIED SECTION

When using this product 

avoid contact with the eyes

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Other information

keep tightly sealed

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/10/2019

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

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

Revised: 6/2019

Document Id: f2274abd-890a-4140-ae41-ec8c65394b74

Set id: 5b4add17-6c3d-4093-826a-2edb41c1d1db

Version: 1

Effective Time: 20190610

Search by Drug Name or NDC

NDC 69070-0306-01 Au Kah Chuen Fugical 2; .05; 9.95 g/100g; g/100g; g/100g Details

Au Kah Chuen Fugical 2; .05; 9.95 g/100g; g/100g; g/100g

Product Information

Package

Package Images

NDC 69070-0306-01 (69070030601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5b4add17-6c3d-4093-826a-2edb41c1d1db Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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