CALAMINE- calamine, pramoxine 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
336.003  336AG

Active ingredients

Calamine 8%

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC,

ELK GROVE VILLAGE, IL 60007

TOPCO VIJa0622 QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Quality Guaranteed

Visit here for more information: http://topbrnds.com/4901jm

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

principal display panel

TopCare Health

COMPARE TO CALADRYL LOTION ACTIVE INGREDIENTS*

NDC 76162-336-30

MEDICATED

Calamine Lotion

EXTERANAL ANALGESIC/SKIN PROTECTANT

For Relief from Pain & Itching Due to:

6 FL OZ (177 mL)

image description

CALAMINE 
calamine, pramoxine hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-336
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 HYDROCHLORIDE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
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:76162-336-30177 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(76162-336)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(76162-336)

Revised: 8/2022
Document Id: f05447b7-b071-4b6f-abfa-b3736a6e52da
Set id: 15d1ae3f-509c-4e6b-8f0c-cf9265680358
Version: 3
Effective Time: 20220824
 
Topco associates LLC