CALAMINE- calamine, pramoxind hcl lotion 
Topco associates LLC

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

Use

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

Dislcaimer

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

Adverse reactions

DIST. BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL

@TOPCO VIJA071

QUESTIONS? 1-888-423-0139

topcare@topco.coM

www.topcarebrand.com

336.002/336AF

principal display panel

TopCare

Health

COMPARE TO

CALADRYL LOTION

ACTIVE INGREDIENTS

MEDICATED

Calamine

Lotion

EXTERANAL ANALGESIC/

SKIN PROTECTANT

Drying Action Plus

Itch Relief for:

Poison Ive, Oak & Sumac

OUR PHARMACISTS RECOMMEND

6 FL OZ (177 mL)

image description

CALAMINE 
calamine, pramoxind hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-336
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)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
HYPROMELLOSES (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:36800-336-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/21/2009
Labeler - Topco associates LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-336)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(36800-336)

Revised: 1/2023
Document Id: 4f9fa34d-9a25-42be-a68a-bb1055b773b0
Set id: f08cf654-d884-4e12-b008-4caf7d9d33e2
Version: 9
Effective Time: 20230113
 
Topco associates LLC