CALAMINE- calamine, pramoxind hcl lotion 
Walgreen CO

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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Medicated Calamine Lotion
336.002/336AF

Active ingredients

Calamine 8%

Pramoxind HCl 1%

Purpose

Skin protectant

External analgesic

Uses

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

Children under 2 years of age - do not use, ask a doctor

Other information

store at room temperature (59°-77°F)

Inactive ingredients

alcohol, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

Rear label text

Distributed by:  WALGREEN CO.

200 WILMOT RD., DERRFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com  (C) 2016 Walgreen Co.

L001621SC

††This product is not manufactured or distributed by Valeant Pharmaceuticals, distributor of Caladryl Lotion.

Walgreens pharmacist recommended

Walgreens Pharmacist survey study.  November 2016.

336.002/336AF

principal display panel

Walgreens

Calahist

Medicated Calamine Lotion/External Analgesic/Skin Protectant

Drying action plus itch relief

Compare to Caladryl Lotion active ingredients ††

6 FL OZ (177 mL)

image description

CALAMINE 
calamine, pramoxind hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED80 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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9114-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/07/2017
Labeler - Walgreen CO (008965063)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(0363-9114)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(0363-9114)

Revised: 1/2023
Document Id: f256efe4-c5bf-4a59-b2db-7908d3411f75
Set id: 856c324d-0683-4a58-a584-0059b0e9b1a5
Version: 8
Effective Time: 20230113
 
Walgreen CO