Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 5b4add17-6c3d-4093-826a-2edb41c1d1db
Route
TOPICAL
Published
Effective Date 2019-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (9.95 g) Ferric Oxide Red (0.05 g) Diphenhydramine (2 g)
Inactive Ingredients
Alcohol Camphor (synthetic) Ceteth-20 Cetostearyl Alcohol Light Mineral Oil Menthol Methylparaben Petrolatum Propylparaben Silicon Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-10

Description

Active ingredient Calamine 10% Diphenhydramine hydrochloride 2%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and 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

Dosage and 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

Description

Active ingredient Calamine 10% Diphenhydramine hydrochloride 2%

Section 44425-7

Other information

keep tightly sealed

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product


avoid contact with the eyes

Section 51727-6

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

Section 51945-4

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

Section 53413-1

Questions or comments? (888) 221-3496 M-F 9am-5pm

you may also report serious side effects to this phone number

Section 55105-1

Purpose

Skin protectant

External analgesic

Section 55106-9

Active ingredient

Calamine 10%

Diphenhydramine hydrochloride 2%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

keep tightly sealed

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product


avoid contact with the eyes

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions or comments? (888) 221-3496 M-F 9am-5pm

you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

Skin protectant

External analgesic

Section 55106-9 (55106-9)

Active ingredient

Calamine 10%

Diphenhydramine hydrochloride 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)