FDA.reportPublic FDA data

Anti-Itch

Manufacturer
Dolgencorp, Inc. | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2016-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:28

Label at a glance#

ProductAnti-Itch
Active ingredientMENTHOL, PRAMOXINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Menthol 1%

Pramoxine hydrochloride 1%

OTC - PURPOSE SECTION

Purpose

Anti-itch, Pain relief

INDICATIONS & USAGE SECTION

Uses

for temporary relief of pain and itching associated with:

  • minor skin irritations
  • minor cuts
  • minor burns
  • rashes due to poison ivy, poison oak or poison sumac
  • scrapes
  • insect bites

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on

  • deep or puncture wounds
  • animals bites
  • serious burns
  • large areas of the body

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes or nose
  • not for prolonged use

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 2 years and older: apply to affected area up to 3 or 4 times daily

children under 2 years: consult a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe vera (aloe barbadensis) leaf juice, diazolidinyl urea, disodium EDTA, eucalyptol, iodopropynyl butylcarbamate, methyl salicylate, mineral oil (parraffinum liquidum), petrolatum, PPG-1 trideceth-6, propylene glycol, sodium acrylates copolymer, steareth-21, stearyl alcohol, thymol,   tocopheryl acetate (vitamin E), triethanolamine, water

SPL UNCLASSIFIED SECTION

Other information

  • store at room temperature
  • for lot no. and exp. date, see crimp of tube or see box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ANTI-ITCH CREAM

NET WT 1 OZ (28 g)

label of anti-itchlabel of anti-itch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN1
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD1
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-407-032020-01-31C16284748780-19d75b9d0-1621-f424-e053-dadaa90a57ceAnti-Itch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-407-03Anti-Itch28 g in 1 TUBECREAM281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-407ANTI-ITCH (MENTHOL AND PRAMOXINE HYDROCHLORIDE) CREAM [DOLGENCORP, INC.]1Legacy NDC, 1 package rows20160702_a26f4840-9a05-45e4-a58d-0aa63729e59c.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-40755910-407-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
EUCALYPTOLRV6J6604TKIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYL SALICYLATELAV5U5022YIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
PPG-1 TRIDECETH-61K7417JX6QIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARETH-2153J3F32P58IACT
STEARYL ALCOHOL2KR89I4H1YIACT
THYMOL3J50XA376EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

Source Document#

Source XML

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
36a97165-e026-65cf-e054-00144ff88e88a26f4840-9a05-45e4-a58d-0aa63729e59c2016-07-01WarningsExact identifier
spl id: 36a97165-e026-65cf-e054-00144ff88e88
spl set id: a26f4840-9a05-45e4-a58d-0aa63729e59c

Reported adverse events (FAERS/openFDA)#

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