LEADER CALAMINE PLUS- zinc oxide lotion lotion 
Cardinal Health, 110 dba Leader

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LEADER Calamine Plus

Calamine 8%

Pramoxine HCl 1%

Adults and children 2 years 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 of 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.

SH Alcohol 38B 2.5%

Camphor

Diazolidinyl Urea

Fragrances

Glycerin

Hydroxypropyl Methylcellulose

Methylparaben

Polysorbate 80

Propylene Glycol

Propylparabaren

Purified water

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

Uses:
temporarily relieves pain and itching associated with:

calamineplus

LEADER CALAMINE PLUS 
zinc oxide lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0400
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
ALCOHOL (UNII: 3K9958V90M)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0400-1177 mL in 1 CONTAINER; Type 0: Not a Combination Product02/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01602/15/2019
Labeler - Cardinal Health, 110 dba Leader (063997360)

Revised: 12/2023
Document Id: 0d1994b2-3c1b-6322-e063-6394a90a1b6c
Set id: 81f29789-f794-1e64-e053-2a91aa0ac85e
Version: 5
Effective Time: 20231222
 
Cardinal Health, 110 dba Leader