FDA.reportPublic FDA data

CoreTex Anti-Itch Gel

Manufacturer
CoreTex Products Inc
Effective date
2024-10-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:22:48

Label at a glance#

ProductCoreTex Anti-Itch Gel
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, CAMPHOR (SYNTHETIC)
Label structure12 sections

Indications and uses

For the temporary relief of itching and pain associated with minor cuts, minor skin irritations and rashes due to insect bites, poison ivy, poison oak, and poison sumac.

Dosage and administration

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: do not use, consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.1%

Diphenhydramine hydrochloride 2%

Zinc acetate 1%

Purpose

OTC - PURPOSE SECTION

Extrenal analgesic

External analgesic

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of itching and pain associated with minor cuts, minor skin irritations and rashes due to insect bites, poison ivy, poison oak, and poison sumac.

Warnings

WARNINGS SECTION

For external use only.

Do Not Use

OTC - DO NOT USE SECTION

  • on chicken pox, blisters or on extensive areas of the skin
  • with any drugs containing diphenhydramine while using this product.
  • Avoid contact with the eyes
  • more than directed

When using the product:

OTC - WHEN USING SECTION

  • Keep out of eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsen or if symptoms persist for 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 Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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:do not use, consult a doctor.

Other Information

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, SD alcohol 40, sodium citrate, water (aqua).

Questions?

OTC - QUESTIONS SECTION

Call: (877) 684-5774

SPL UNCLASSIFIED SECTION

Made in USA for CoreTex Products, Inc. Erwin, TN 37650 (877) 684-5774

PRINCIPAL DISPLAY PANEL 65753-400-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

400-02400-02

Principal Display Panel 65753-400-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

400-04400-04

Principal Display Panel 65753-13 and -14

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

400-1314400-1314

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2263170camphor 0.1 % / diphenhydrAMINE HCl 2 % / zinc acetate 1 % Topical GelPSN6
2263170camphor 0.001 MG/MG / diphenhydramine hydrochloride 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSCD6
2263170camphor 0.001 MG/MG / diphenhydramine HCl 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSY6
2263170camphor 0.1 % / diphenhydramine HCl 2 % / zinc acetate 1 % Topical GelSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
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
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-400-02CoreTex Anti-Itch Gel59 mL in 1 BOTTLEGEL596
65753-400-04CoreTex Anti-Itch Gel177 mL in 1 BOTTLEGEL1776
65753-400-13CoreTex Anti-Itch Gel1 mL in 1 POUCHGEL16
65753-400-13CoreTex Anti-Itch Gel25 in 1 CONTAINERGEL256
65753-400-14CoreTex Anti-Itch Gel300 in 1 CONTAINERGEL3006
65753-400-14CoreTex Anti-Itch Gel1 mL in 1 POUCHGEL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-400CORETEX ANTI-ITCH GEL (CAMPHOR, DIPHENHYDRAMINE, ZINC ACETATE) GEL [CORETEX PRODUCTS INC]6Legacy NDC, 6 package rows20241008_9849da49-d867-fae5-e053-2a95a90a399c.zip

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
65753-40065753-400-04, 65753-400-02, 65753-400-13, 65753-400-14

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
METHYLCELLULOSE (1500 CPS)P0NTE48364IACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL 1-ALLYL ETHERQRB8092KPKIACT
SODIUM CITRATE1Q73Q2JULRIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

Source Document#

Source XML · Source PDF

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
23d94b44-5be0-f9fc-e063-6294a90a1e749849da49-d867-fae5-e053-2a95a90a399c2024-10-06WarningsExact identifier
spl id: 23d94b44-5be0-f9fc-e063-6294a90a1e74
spl set id: 9849da49-d867-fae5-e053-2a95a90a399c

Reported adverse events (FAERS/openFDA)#

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