Label: ITCHY BITTEN- eucalyptus peppermint oil gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71157-0018-1 - Packager: Kelada Creative Group
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated October 16, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ITCHY BITTEN
eucalyptus peppermint oil gelProduct 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)