TOPCARE CALAMINE- calamine 8% and zinc oxide 8% lotion lotion

TopCare Calamine by

Drug Labeling and Warnings

TopCare Calamine by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Calamine 8% and Zinc Oxide 8%

PURPOSE

Skin protectant

INDICATIONS & USAGE

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.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

Bentonite magma, calcium hydroxide, glycerin, purified water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE CALAMINE 
calamine 8% and zinc oxide 8% lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-702
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
CARRAGEENAN (UNII: 5C69YCD2YJ)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-702-96	177 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/16/2019

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - Humco Holding Group, Inc (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc		825672884	analysis(36800-702) , manufacture(36800-702) , label(36800-702) , pack(36800-702)