Label: BORAGO LAVENDER lotion
- NDC Code(s): 48951-2144-5
- Packager: Uriel Pharmacy Inc.
- 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 February 1, 2024
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Warnings: FOR EXTERNAL USE ONLY.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist,
or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes.SHAKE WELL BEFORE USE.
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INGREDIENTS AND APPEARANCE
BORAGO LAVENDER
borago lavender lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-2144 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELILOTUS INDICUS SEED (UNII: F22I9R6Q0X) (MELILOTUS INDICUS SEED - UNII:F22I9R6Q0X) MELILOTUS INDICUS SEED 1 [hp_X] in 1 g HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 1 [hp_X] in 1 g BORAGE (UNII: PB618V0K2W) (BORAGE - UNII:PB618V0K2W) BORAGE 1 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) SORBIC ACID (UNII: X045WJ989B) TEA TREE OIL (UNII: VIF565UC2G) CITRUS PARADISI SEED (UNII: 12F08874Y7) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) LAVENDER OIL (UNII: ZBP1YXW0H8) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-2144-5 120 g in 1 TUBE; Type 0: Not a Combination Product 12/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/09/2021 Labeler - Uriel Pharmacy Inc. (043471163) Establishment Name Address ID/FEI Business Operations Uriel Pharmacy Inc. 043471163 manufacture(48951-2144)