CALAMINE- calamine, pramoxine hcl lotion 
Amazon.Com Services 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 Anti-Itch Lotion
336.003/336AG

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

DISTRIBUTED BY: Amazon.com, Services, LLC

Seattle, WA 98109     1-877-485-0385

2022 Amazon.com, Inc. or its affiliated.

All rights reserved.   www.amazon.com/amazonbasics

"Alexa, reorder Amazon Basics Anti-Itch Lotion." alexa

Principal display panel

amazon basics

medicated

calamine lotion

External Analgesic

Skin Protectant

Anti-itch lotion

6 FL OZ (177 mL)

image description

CALAMINE 
calamine, pramoxine hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-436
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 (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:72288-436-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/21/2018
Labeler - Amazon.Com Services LLC (128990418)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(72288-436)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(72288-436)

Revised: 9/2023
Document Id: c0ea46cc-7ea3-4ec5-a311-f6ca7684a5d2
Set id: aceb0b10-8c90-4a06-8c47-cd1a2b4676a3
Version: 3
Effective Time: 20230907
 
Amazon.Com Services LLC