CALAMINE- calamine, pramoxind hcl lotion 
Consumer Product Partners, LLC

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Good Sense 336.003/336AG
Medicated Calamine Lotion

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

Disclaimer

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl Lotion Calamine Plus Itch Reliever.

Adverse reaction

Distributed by Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

Good Sense is a registered trademark of L. Perrigo Company

Principal display panel

NDC 11344-336-30

GoodSense

MEDICATED

Calamine Itch Relief Lotion

EXTERNAL ANALGESIC/SKIN PROTECTANT

Pain and itch reliever

Compare to active ingredients of Caladryl Lotion*

6 FL OZ (177 mL)

image description

CALAMINE 
calamine, pramoxind hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-336
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:11344-336-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01609/08/2016
Labeler - Consumer Product Partners, LLC (119091520)
Registrant - Consumer Product Partners, LLC (119091520)
Establishment
NameAddressID/FEIBusiness Operations
Consumer Product Partners, LLC119091514manufacture(11344-336)

Revised: 3/2024
Document Id: 13794ba4-f1ae-f21e-e063-6394a90ab62e
Set id: 482898e5-ec45-4582-b61b-cedc1ed32a92
Version: 3
Effective Time: 20240312
 
Consumer Product Partners, LLC