TOPCARE CALAGESIC- calamine and pramoxine hydrochloride lotion lotion

TopCare Calagesic by

Drug Labeling and Warnings

TopCare Calagesic 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%

Pramoxine Hydochloride 1%

PURPOSE

Skin Protectant

External analgesic

INDICATIONS & USAGE

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.

WARNINGS

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 yrs. of age. Consult a doctor before use.

INACTIVE INGREDIENT

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE CALAGESIC 
calamine and pramoxine hydrochloride lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-268
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-268-96	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(36800-268) , pack(36800-268) , label(36800-268) , manufacture(36800-268)