Zax's Original Bug Bite & Itch Cream

Manufacturer
Zax Healthcare Inc. | Canadian Custom Packaging
Effective date
2024-10-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:30:10

Label at a glance#

ProductZaxs Original Bug Bite and Itch
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, poison ivy, oak or sumac, and insect bites.

Dosage and administration

•Apply as needed. •As soon as bug bite itching occurs.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Colloidal Oatmeal 5%

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, poison ivy, oak or sumac, and insect bites.

Warnings

WARNINGS SECTION

•For external use only.

•When using this product do not get into eyes or mucous membranes. If this occurs, rinse thoroughly with water.

•If conditions worsen, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

•Stop use if:

•irritation develops.

•If you are allergic to any ingredient in this product.

•If hypersensitivity occurs consult a doctor

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, consult a Poison Control Centre immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

•Apply as needed.

•As soon as bug bite itching occurs.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol

Arnica Montana Flower Extract

Caprylic/Capric Glycerides

Caprylyl Glycol

Ceteareth-20

Cetearyl Alcohol

Cetyl Alcohol

Citric Acid

Cocos Nucifera (Coconut) Oil

Glycerin

Glyceryl Stearate

Glycine Soja (Soybean) Oil

Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract

Melaleuca Alternifolia (Tea Tree) Leaf Oil

Menthol

Phenoxyethanol

Sorbic Acid

Tocopherol

Water

Xanthum Gum

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube LabelTube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595494colloidal oatmeal 5 % Topical CreamPSN1
1595494colloidal oatmeal 50 MG/ML Topical CreamSCD1
1595494colloidal oatmeal 5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82186-155-01Zaxs Original Bug Bite and Itch28 g in 1 TUBECREAM281
82186-155-01Zaxs Original Bug Bite and Itch1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82186-155ZAXS ORIGINAL BUG BITE AND ITCH (COLLOIDAL OATMEAL) CREAM [ZAX HEALTHCARE INC.]12 package rows20241029_244d362c-acf2-3c7a-e063-6394a90a607b.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82186-15582186-155-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
244d3667-0b17-f557-e063-6294a90a1541244d362c-acf2-3c7a-e063-6394a90a607b2024-10-12WarningsExact identifier
spl id: 244d3667-0b17-f557-e063-6294a90a1541
spl set id: 244d362c-acf2-3c7a-e063-6394a90a607b

Reported adverse events (FAERS/openFDA)#

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