Label: VIOLA COMP. gel
- NDC Code(s): 48951-9359-5
- 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 November 7, 2023
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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. Do not use if safety
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INGREDIENTS AND APPEARANCE
VIOLA COMP.
viola comp. gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-9359 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 2 [hp_X] in 1 g ANTIMONY (UNII: 9IT35J3UV3) (ANTIMONY - UNII:9IT35J3UV3) ANTIMONY 5 [hp_X] in 1 g URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA 1 [hp_X] in 1 g VIOLA ODORATA FLOWERING TOP (UNII: 04BPC87I4H) (VIOLA ODORATA FLOWERING TOP - UNII:04BPC87I4H) VIOLA ODORATA FLOWERING TOP 1 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) SODIUM ALGINATE (UNII: C269C4G2ZQ) SORBIC ACID (UNII: X045WJ989B) GLYCERIN (UNII: PDC6A3C0OX) CITRUS PARADISI SEED (UNII: 12F08874Y7) LAVENDER OIL (UNII: ZBP1YXW0H8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-9359-5 60 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2009 Labeler - Uriel Pharmacy Inc. (043471163) Establishment Name Address ID/FEI Business Operations Uriel Pharmacy Inc. 043471163 manufacture(48951-9359)