CLEAR ANTI ITCH- pramoxine hcl, zinc acetate lotion 
United Natural Foods, Inc. dba UNFI

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

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

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

Distributed by UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

Principal display panel

compare to Caladryl Clear Lotion active ingredients*

NDC 41163-099-30

EQUALINE

clear anti-itch lotion

external analgesic

skin protectant

drying action

plus itch relief

6 FL OZ (177mL)

image description

CLEAR ANTI ITCH 
pramoxine hcl, zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-099
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 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)  
HYPROMELLOSES (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:41163-099-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/02/2005
Labeler - United Natural Foods, Inc. dba UNFI (943556183)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(41163-099)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(41163-099)

Revised: 5/2023
Document Id: 419323f9-dde4-44b0-b115-f734f2cc2fe8
Set id: 242adc68-f9e0-4f69-a580-a107d1634b50
Version: 13
Effective Time: 20230511
 
United Natural Foods, Inc. dba UNFI