CLEAR ANTI ITCH- pramoxine hcl, zinc acetate lotion 
TOPCO ASSOCIATES

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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Top Care 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 TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL60007

TOPCP VIJA0622 Questions? 1-888-423-0139

topcare@topco.com  www.topcarebrand.com

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

This product is not manufactured of distributed by Bausch Health US, LLC,

Distributer of Caladryl Clear Lotion

Quality Guaranteed

principal display panel

TopCare health

NDC 36800-218-30

COMPARE TO CALADRYL CLEAR LOTION ACTIVE INGREDIENTS

Clear Anti-Itch Lotion

EXTERNAL ANALGESIC / SKIN PROTECTANT

For Relief of Pain and Itching Due To:

6 FL OZ (177 mL)

image description

CLEAR ANTI ITCH 
pramoxine hcl, zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-218
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:36800-218-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/03/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/03/2009
Labeler - TOPCO ASSOCIATES (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-218)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(36800-218)

Revised: 8/2022
Document Id: 131543cb-8203-4ba5-97c5-66e083ca15cd
Set id: 8d3d1ff5-4868-495d-807c-e45aa2176f63
Version: 17
Effective Time: 20220829
 
TOPCO ASSOCIATES