FDA.reportPublic FDA data

Clear Anti Itch

Product NDC
41163-099
11-digit product format
411630099
Labeler code
41163
Product ID
41163-099_5aa9775d-d73c-927e-e063-6394a90a252b
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine HCl, Zinc acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-04-02
Substance
PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength
10; 1 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Clear Anti Itch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC ACETATE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234546Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242adc68-f9e0-4f69-a580-a107d1634b50Available on FDA.report

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
41163-099-30Clear Anti Itch177 mL in 1 BOTTLE, PLASTICLOTION17716

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-099-30ML - Milliliter41163-0991ca4a7fa-d2cf-4fba-99f0-43b935d3019a12017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07ACLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
PRAMOXINEACTIVE MOIETY068X84E056CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
POLYSORBATE 40INACTIVE INGREDIENTSTI11B5A2XCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM393CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [SUPERVALU, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-099CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [UNITED NATURAL FOODS, INC. DBA UNFI]14Current NDC, Legacy NDC, 1 package rows20240915_242adc68-f9e0-4f69-a580-a107d1634b50.zip

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 3 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMist White PetrolatumWHITE PETROLATUMDukal LLC598e9d46-6450-af60-e063-6394a90a3a6b2026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
application number: M016
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
application number: M016
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
application number: M016
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
application number: M016
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
application number: M016
Eczema Skin Relief CreamCOLLOIDAL OATMEALCVS Health98fac854-f7b0-4c6e-888d-1bdc6b9323b92026-08-17WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
application number: M016
Intimate CareGelHYALURONIC ACIDGuangzhou Yilong Cosmetics.,Ltd5918d204-52db-e6d0-e063-6394a90ab78c2026-08-14WarningsExact identifier
application number: M016
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
application number: M016
Nail Renewal LiquidGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.581f7192-fc17-a706-e063-6394a90a3ffa2026-08-11WarningsExact identifier
application number: M016
Intertrigo Relief CreamGLYCERINShantou South Moon Biotechnology Co., Ltd.587220c9-0ae9-3438-e063-6394a90a0a862026-08-07WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN242adc68-f9e0-4f69-a580-a107d1634b5016
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD242adc68-f9e0-4f69-a580-a107d1634b5016
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY242adc68-f9e0-4f69-a580-a107d1634b5016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-099-3041163009930177 mL in 1 BOTTLE, PLASTIC (41163-099-30) 177 ml2005-04-020000-00-00NoNoCurrent