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.

Top Care CalamineTCCal.jpgcl

TOPCARE CALAMINE 
calamine 8% and zinc oxide 8% lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-702
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-702-96177 mL in 1 CONTAINER; Type 0: Not a Combination Product07/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01607/16/2019
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114analysis(36800-702) , manufacture(36800-702) , label(36800-702) , pack(36800-702)

Revised: 12/2023
Document Id: 0ccb3ccc-3531-2d08-e063-6394a90ac91a
Set id: 8dcf134e-0427-0c43-e053-2995a90a7c26
Version: 5
Effective Time: 20231218
 
TOPCO ASSOCIATES LLC