FDA.reportPublic FDA data

Clear Anti Itch

Product NDC
41163-099
11-digit product format
411630099
Labeler code
41163
Product ID
41163-099_4af78681-4352-a506-e063-6394a90a0841
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

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 Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, FM5526K07A
Rxcui1234546

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

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