TOPCARE CALACLEAR- pramoxine hydrochloride and zinc acetate lotion lotion 
TOPCO ASSOCIATES LLC

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Top Care Calaclear Lotion

Pramoxine HCl 1%

Zing Acetate 0.1%

External Analgesic

Skin Protectant

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

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using

on children under 2 years of age.

When using this product. Discontinue use if

condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor.

Keep out of reach of children.

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

Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.
Children under 2 years of age: Consult a doctor before use.

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

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

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TOPCARE CALACLEAR 
pramoxine hydrochloride and zinc acetate lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-267
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
ALCOHOL (UNII: 3K9958V90M)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-267-96177 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, LLC118564114manufacture(36800-267) , label(36800-267) , analysis(36800-267) , pack(36800-267)

Revised: 12/2023
Document Id: 0ccb3e8a-3d01-1364-e063-6294a90a70e8
Set id: 8dce8817-b905-4064-e053-2995a90a071e
Version: 5
Effective Time: 20231218
 
TOPCO ASSOCIATES LLC