ZAXS ORIGINAL BUG BITE AND ITCH- colloidal oatmeal cream

Zaxs Original Bug Bite and Itch by

Drug Labeling and Warnings

Zaxs Original Bug Bite and Itch by is a Otc medication manufactured, distributed, or labeled by Zax Healthcare Inc., Canadian Custom Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Colloidal Oatmeal 5%

Active Ingredient

Colloidal Oatmeal 5%

Purpose

Skin Protectant

Uses

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

Warnings

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

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

Directions

Apply as needed.

As soon as bug bite itching occurs.

Inactive Ingredients

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

Store at room temperature.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZAXS ORIGINAL BUG BITE AND ITCH 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82186-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
COCONUT OIL (UNII: Q9L0O73W7L)
MENTHOL (UNII: L7T10EIP3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)
TOCOPHEROL (UNII: R0ZB2556P8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALCOHOL (UNII: 3K9958V90M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SOYBEAN OIL (UNII: 241ATL177A)
WITCH HAZEL (UNII: 101I4J0U34)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white (Off white to yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82186-155-01	1 in 1 CARTON	10/28/2024
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/28/2024

Labeler - Zax Healthcare Inc. (247378271)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Custom Packaging		207062514	manufacture(82186-155)