FDA.reportPublic FDA data

Anti-Itch Cream Maximum Relief

Manufacturer
Natureplex LLC
Effective date
2025-08-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:12:28

Label at a glance#

ProductAnti Itch Maximum Relief
Active ingredientPramoxine Hydrochloride, Menthol, Unspecified Form
Label structure9 sections

Dosage and administration

adults and children 2 years old and older: apply to affected area not more than 3 to 4 times daily children under 2 years old: ask a doctor

Storage and handling

store at 15 to 30° C (59 to 86° F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Menthol 1%Topical Analgesic
Pramoxine hydrochloride 1%Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with minor skin irritations, minor burns, minor cuts, sunburns, scrapes, insect bites, and rashes due to poison ivy, poison oak, or poison sumac

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes and nose.

Not for prolonged use.

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness, irritation, swelling, or pain develops, persists, or increases

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years old and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years old: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 15 to 30° C (59 to 86° F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, carbomer, cetearyl alcohol, DMDM hydantoin, glycerin, polysorbate 60, propylene glycol, purified water, triethanolamine

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Natureplex™

MAXIMUM RELIEF

Medicated
Anti-Itch Cream

NET WT. 1.5 Oz. (42.5g)

Principal Display Panel - 42.5 g Tube Box
Principal Display Panel - 42.5 g Tube Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN4
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD4
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
67234-008-01Anti Itch Maximum Relief42 g in 1 TUBECREAM424
67234-008-01Anti Itch Maximum Relief1 in 1 BOXCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A1
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L51
MentholACTIVE MOIETYL7T10EIP3A1
PramoxineACTIVE MOIETY068X84E0561
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27E1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67234-00867234-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Pramoxine Hydrochloride88AYB867L5ACTIB
Menthol, Unspecified FormL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
DMDM HYDANTOINBYR0546TOWIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
2 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact 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
Anti Itch Maximum ReliefPRAMOXINE HYDROCHLORIDE AND MENTHOLNatureplex LLC75de3d5e-ecbe-4d04-a39d-792200e6ee322025-08-28WarningsExact identifier
ndc (package): 67234-008-01
ndc (product): 67234-008
ndc11 (package): 67234000801
spl id: eba79205-9b9e-495e-a57c-c1d980a90e22
spl set id: 75de3d5e-ecbe-4d04-a39d-792200e6ee32

Reported adverse events (FAERS/openFDA)#

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