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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

TOPCO ASSOCIATES LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin protectant dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Authorization status:

OTC monograph final

Summary of Product characteristics

TOPCARE CALAMINE- CALAMINE 8% AND ZINC OXIDE 8% LOTION LOTION
TOPCO ASSOCIATES LLC
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TOP CARE CALAMINE LOTION
Calamine 8% and Zinc Oxide 8%
Skin protectant
dries the oozing and weeping o poison ivy, poison oak, and poison
sumac.
For external use only. Use only as directed.
Avoid contact with eyes and mucous membranes.
Ask a doctor before using on chilren 2 years of age.
In case of accidental ingestion, seek professional assistance or
contact a Poison Control
center immediately.
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 2 years of age: Consult a doctor before use.
Bentonite magma, calcium hydroxide, glycerin, purified water.
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
TOPCO ASSOCIATES LLC
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 Drug
M016
07/16/2019
LABELER -
TOPCO ASSOCIATES LLC (006935977)
REGISTRANT -
Pharma Nobis, LLC (118564114)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Pharma Nobis,
LLC
118564114
analysis(36800-702) , manufacture(36800-702) , label(36800-702) ,
pack(3