Cortex Anti-itch Gel

SPL v6

SPL

SPL Set ID 9849da49-d867-fae5-e053-2a95a90a399c

Route

TOPICAL

Published

Effective Date 2022-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (2 g) Zinc Cation (1 g) Camphor (synthetic) (0.1 g)

Inactive Ingredients

Methylcellulose (1500 Cps) Propylparaben Glycerin Propylene Glycol 1-allyl Ether Sodium Citrate Diazolidinyl Urea Methylparaben Alcohol Water Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-11-25

Description

Camphor 0.1% Diphenhydramine hydrochloride 2% Zinc acetate 1%

Purpose

Extrenal analgesic External analgesic Skin protectant

Medication Information

Purpose

Extrenal analgesic

External analgesic

Skin protectant

Description

Camphor 0.1% Diphenhydramine hydrochloride 2% Zinc acetate 1%

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.

Section 42229-5

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

Warnings

For external use only.

Directions

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.

Do Not Use

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

Questions?

Call: (877) 684-5774

Other Information

protect this product from excessive heat and direct sun.

Active Ingredients

Camphor 0.1%

Diphenhydramine hydrochloride 2%

Zinc acetate 1%

Inactive Ingredients

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

Principal Display Panel

When Using the Product:

Keep out of eyes.

Stop Use and Ask A Doctor If

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.

If swallowed get medical help or contact Poison Control center right away.

Structured Label Content

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.

Section 42229-5 (42229-5)

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

Purpose

Extrenal analgesic

External analgesic

Skin protectant

Warnings

For external use only.

Directions

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.

Do Not Use

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

Questions?

Call: (877) 684-5774

Other Information

protect this product from excessive heat and direct sun.

Active Ingredients

Camphor 0.1%

Diphenhydramine hydrochloride 2%

Zinc acetate 1%

Inactive Ingredients

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Principal Display Panel

When Using the Product: (When using the product:)

Keep out of eyes.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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. (Keep out of reach of children.)

If swallowed get medical help or contact Poison Control center right away.

Advanced Ingredient Data

[{"name": "METHYLCELLULOSE (1500 CPS)", "unii": "P0NTE48364", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL 1-ALLYL ETHER", "unii": "QRB8092KPK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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.", "42229-5": "Made in USA for CoreTex Products, Inc. Erwin, TN 37650 (877) 684-5774", "Purpose": "Extrenal analgesic External analgesic Skin protectant", "Warnings": "For external use only.", "Directions": "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.", "Do Not Use": "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", "Questions?": "Call: (877) 684-5774", "Other Information": "protect this product from excessive heat and direct sun.", "Active Ingredients": "Camphor 0.1% Diphenhydramine hydrochloride 2% Zinc acetate 1%", "Inactive Ingredients": "citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, SD alcohol 40, sodium citrate, water (aqua).", "When using the product:": "Keep out of eyes.", "Stop use and ask a doctor if": "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.": "If swallowed get medical help or contact Poison Control center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:40.881523 · Updated: 2026-03-14T23:03:52.479021