CLEAR ANTI ITCH- pramoxine hcl, zinc acetate 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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Clear Anti-Itch Lotion 
218.002/218AF

Active Ingredients

Pramoxine HCl 1%

Zinc acetate 0.1%

Purpose

External analgesic

Skin protectant

Use

Warnings

For external use only

When using this product

do not get into eyes

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 - ask a doctor

Other information

store at room temperature (59°-77°F)

Inactive ingredients

alcohol, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, water

DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

2018 Amazon.com, Inc. or its afiliated.

All rights reserved. Solimo and all related logos are are trademarks of Amazon.com, Inc or its affiliates.

principal display panel

SOLIMO

Medicated Calamine Lotion

EXTERNAL ANALGESIC

SKIN PROTECTANT

Anti-itch lotion

6 FL OZ (177 mL)

image description

CLEAR ANTI ITCH 
pramoxine hcl, zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-218
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
benzoic acid (UNII: 8SKN0B0MIM)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
sodium citrate (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72288-218-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2018
Labeler - Amazon.Com Services LLC (128990418)
Registrant - Vi-Jon Inc (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc790752542manufacture(72288-218)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc088520668manufacture(72288-218)

Revised: 7/2022
Document Id: 9b426d17-7aea-43fa-bdfe-a0138283aa46
Set id: e10fd91c-60df-41d1-accd-fc9aed8d8354
Version: 3
Effective Time: 20220701
 
Amazon.Com Services LLC