Drug Facts

Active Ingredients

Calamine 8% and Zinc Oxide 8%

Purpose

Skin protectant

Uses

Dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren 6 months of age.

When using this product

Discontinue use if condition worsens or does not improve within 7 days and consult a doctor.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

Directions

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.

Children under 6 months of age: Consult a doctor before use.

Other information

Store at room temperature 13-30C (50-86F)

Inactive ingredients

Bentonite magma, calcium hydroxide, glycerin, purified water.

assured calamine

assured calamine.jpg

ASSURED CALAMINE
calamine 8% and zinc oxide 8% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-4130
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	160 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-4130-6	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	01/27/2020

Labeler - Greenbriar International (610322518)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	label(33992-4130) , manufacture(33992-4130) , analysis(33992-4130) , pack(33992-4130)

Assured Calamine