ITCHY BITTEN- eucalyptus peppermint oil gel

Itchy Bitten by

Drug Labeling and Warnings

Itchy Bitten by is a Homeopathic medication manufactured, distributed, or labeled by Kelada Creative Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Eucalyptus Oil .17%

Peppermint Oil.17%

PURPOSE

Temporarily relieves itching and discomfort associated with irritation, inflammation, and rashes due to insect bites, stings, poison ivy, oak and sumac

WARNINGS

For external use only

Do not use other than as directed

When using this product

• avoid contact with eyes and mucous membranes
• do not apply to wounds or broken skin

INDICATIONS & USAGE

Temporarily relieves itching and discomfort associated with irritation, inflammation, and rashes due to insect bites, stings, poison ivy, oak and sumac​

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

INACTIVE INGREDIENT

Organic Extra Virgin Olive Oil, Sweet Almond Oil, Organic Wild Harvested Chickweed Oil, Beeswax, Organic Marigold Oil, French Lavender Essential Oil, Spanish Rosemary Essential Oil, Natural Vitamin E.

DOSAGE & ADMINISTRATION

• Adults and children 3 years of age and older; lightly apply to affected area not more than 5 times daily
• Children under 3 years of age; ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ITCHY BITTEN 
eucalyptus peppermint oil gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71157-0018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	3 g  in 90 mL
CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB) (CORYMBIA CITRIODORA LEAF OIL - UNII:M63U6N96EB)	CORYMBIA CITRIODORA LEAF OIL	3 g  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
STELLARIA MEDIA LEAF (UNII: E6M924345X)
WHITE WAX (UNII: 7G1J5DA97F)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSEMARY OIL (UNII: 8LGU7VM393)
OLIVE OIL (UNII: 6UYK2W1W1E)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALMOND OIL (UNII: 66YXD4DKO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71157-0018-1	90 mL in 1 CAN; Type 0: Not a Combination Product	01/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/09/2017

Labeler - Kelada Creative Group (014340121)

Registrant - Kelada Creative Group (014340121)

Establishment
Name	Address	ID/FEI	Business Operations
Kelada Creative Group		014340121	manufacture(71157-0018)