CALAMINE CLEAR- pramoxine hydrochloride and zinc acetate lotion lotion 
Cardinal Health, 110 dba Leader

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader Calamine Clear

Pramoxine HCl 1%

Zinc Acetate 0.1%

External Analgesic & Skin Protectant

Temporarily Relieves Pain and Itching Associated with:

rashes due to poison ivy, poison oak, or poison sumac
insect bites
minor skin irritation
minor cuts
dries the oozing and weeping of poison ivy, poison oak and poison sumac

For external use only. Use only as directed.

Acoid contact with eyes and mucous membranes

Ask a doctor before using on children under 2 years of age.

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

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 fo the affected area using cotton or soft cloth, not more than 3 to 4 times dialy as needed for comfort.

SD Alcohol 38B 2.5%

Camphor

Diazolidinyl Usea

Fragrances

Glycerin

Hydroxypropyl Methylcellulose

Methylparaben

Polysorbate 80

Propylene Glycol

Propylparaben

Purified Water

calclear

CALAMINE CLEAR 
pramoxine hydrochloride and zinc acetate lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0397
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
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0397-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/15/2019
Labeler - Cardinal Health, 110 dba Leader (063997360)

Revised: 3/2022
Document Id: da5cc677-d080-1234-e053-2995a90a1e89
Set id: 7f733c0a-82b2-d3b0-e053-2991aa0a6b0f
Version: 4
Effective Time: 20220316
 
Cardinal Health, 110 dba Leader