Itchy/Bitten

ITCHY BITTEN- eucalyptus peppermint oil gel
Kelada Creative Group

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Itchy/Bitten

Eucalyptus Oil .17%

Peppermint Oil.17%

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

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

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

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.

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

Itchy

ITCHY BITTEN
eucalyptus peppermint oil gel

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Kelada Creative Group (014340121)

Registrant - Kelada Creative Group (014340121)

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