TOPCARE CALAGESIC- calamine and pramoxine hydrochloride lotion lotion 
TOPCO ASSOCIATES LLC

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Top Care Calagesic Lotion

Calamine 8%

Pramoxine Hydochloride 1%

Skin Protectant

External analgesic

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

For external use only. Use only as directed.

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

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

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.

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

Top Care Calagesic 2022TCGesig.jpg

TOPCARE CALAGESIC 
calamine and pramoxine hydrochloride lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-268
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-268-96177 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(36800-268) , pack(36800-268) , label(36800-268) , manufacture(36800-268)

Revised: 12/2023
Document Id: 0ccb3962-d499-0a6c-e063-6294a90a0d41
Set id: 8dced3ea-147b-3d46-e053-2a95a90aa1c0
Version: 5
Effective Time: 20231218
 
TOPCO ASSOCIATES LLC