CALAMINE- calamine, pramoxine hcl lotion 
Meijer Distribution

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
336.003/AG

Active ingredients

Calamine 8%

Pramoxine HCl 1%

Purpose

Skin protectant

External analgesic

Uses

Warnings

For external use only

When using this product

Stop use and ask a doctor

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, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

Our Quality Guarantee

WWW.MEIJER.COM/SATISFACTION

*This product is not manufactured

or distributed by Bausch Health US,

LLC, distributer of Caladryl Lotion

Calamine Plus Itch Reliever

DISTRIBUTED BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Principal Panel Display

NDC 79481-0336-1

Compare to Caladryl Lotion*

MEDICATED

calamine

lotion

External Analgesic/Skin Protectant

Drying Action Plus Itch Relief

Relieves itching due to insect

bites, poison oak or ivy, or

other minor skin irritation

6 FL OZ (177 mL)

Empty & Replace Cap

Plastic Bottle

how2recycle.info

image description

CALAMINE 
calamine, pramoxine hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0336
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)  
benzyl alcohol (UNII: LKG8494WBH)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
phenoxyethanol (UNII: HIE492ZZ3T)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
propylene glycol (UNII: 6DC9Q167V3)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
water (UNII: 059QF0KO0R)  
xanthan gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79481-0336-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/17/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/17/2009
Labeler - Meijer Distribution (006959555)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(79481-0336)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(79481-0336)

Revised: 9/2022
Document Id: d876e0c9-72a0-4954-92ae-4281d0e5da2d
Set id: 6b369ef2-fd54-4931-a9eb-0fb42834c2ef
Version: 3
Effective Time: 20220926
 
Meijer Distribution