CLEAR ANTI-ITCH- pramoxine hcl, zinc acetate lotion 
Retail Business 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

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 - 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

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl® Clear® Lotion

DISTRIBUTED BY

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

1-833-992-3872

Quality guaranteed or your money back.

Principal display panel

CAREONE

Clear Anti-Itch Lotion

EXTERNAL ANALGESIC/

SKIN PROTECTANT

Drying Action

Plus Itch Relief

PRAMOXINE HCl 1%

ZINC ACETATE 0.1%

Compare to the active ingredents of Caladryl Clear Lotion*

6 FL OZ (177mL)

image description

CLEAR ANTI-ITCH 
pramoxine hcl, zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-218
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 ACETATE1.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
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:72476-218-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34703/22/2016
Labeler - Retail Business Services, LLC (967989935)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(72476-218)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(72476-218)

Revised: 4/2023
Document Id: c167042e-1896-4c33-93b6-9c1375880455
Set id: a80b8fee-2dd9-4640-a4f8-4cf940df8563
Version: 14
Effective Time: 20230424
 
Retail Business Services, LLC