FDA.reportPublic FDA data

Top Care 218.002/218AF Clear Anti-Itch Lotion

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
21
Source
full-release
Hydrated at
2026-06-01 01:44:20

Label at a glance#

ProductClear Anti Itch
Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC ACETATE
Label structure13 sections

Indications and uses

for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac dries the oozing and weeping of poison:  ivy oak sumac

Dosage and administration

shake well before applying was affected are of skin 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

Storage and handling

store at room temperature (59°-77°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Zinc acetate 0.1%

Purpose

OTC - PURPOSE SECTION

External analgesic

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
  • dries the oozing and weeping of poison: 
  • ivy
  • oak
  • sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • before applying was affected are of skin

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

STORAGE AND HANDLING SECTION

store at room temperature (59°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

©TOPCO VIJA0622 Questions? 1-888-423-0139

topcare@topco.com  www.topcarebrand.com

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

Quality Guaranteed

Disclaimer

SPL UNCLASSIFIED SECTION

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

principal display panel

PACKAGE LABEL.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:

  • Poison Ivy, Oak or Sumac
  • Insect Bites
  • Minor Skin Irritations

6 FL OZ (177 mL)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN21
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD21
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY21

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-218-30Clear Anti Itch177 mL in 1 BOTTLE, PLASTICLOTION17721

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-218-30ML - Milliliter36800-218b6707b3a-e7a0-4720-a0ac-71dc1b8a7e1412024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L51
ZINC ACETATEACTIVE INGREDIENTFM5526K07A1
PRAMOXINEACTIVE MOIETY068X84E0561
ZINC CATIONACTIVE MOIETY13S1S8SF371
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q9411
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW41
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POLYSORBATE 40INACTIVE INGREDIENTSTI11B5A2X1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3931
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-21836800-218-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BENZOIC ACID8SKN0B0MIMIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LAVENDER OILZBP1YXW0H8IACT
POLYSORBATE 40STI11B5A2XIACT
ROSEMARY OIL8LGU7VM393IACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
ZINC ACETATEFM5526K07AACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 40POLYSORBATE 40STI11B5A2XLOTION / TOPICAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 40POLYSORBATE 40STI11B5A2XLOTION / TOPICAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATETopco Associates LLC8d3d1ff5-4868-495d-807c-e45aa2176f632026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 36800-218-30
ndc (product): 36800-218
ndc11 (package): 36800021830
spl id: 4ab81c23-56ef-2b5b-e063-6294a90abe9c
spl set id: 8d3d1ff5-4868-495d-807c-e45aa2176f63

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.