Label: ROSMARINUS LAVANDULA gel
- NDC Code(s): 48951-8375-5
- 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 June 2, 2021
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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ACTIVE INGREDIENT
Active Ingredients: Prunus spinosa (Blackthorn) 2X, Urtica urens (Small nettle) 5X, Anus (Bovine anus) 8X, Conchae (Oyster shells) 8X,Cutis feti. fem. (Porcine Skin - fetal, female) 8X, Funiculus umbilicalis (Bovine umbilical cord) 8X, Pudendum femin. (Bovine female external genitals) 8X, Stannum met. (Metallic tin) 8X, Pars fetalis - placenta (Bovine fetal placenta) 11X
- 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 seal is broken or missing. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROSMARINUS LAVANDULA
rosmarinus lavandula gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-8375 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SLOE (UNII: 3MLB4858X7) (SLOE - UNII:3MLB4858X7) SLOE 2 [hp_X] in 1 g URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS 5 [hp_X] in 1 g BEEF (UNII: 4PIB2155QP) (BEEF - UNII:4PIB2155QP) BEEF 8 [hp_X] in 1 g OSTREA EDULIS SHELL (UNII: 49OY13BE7Z) (OSTREA EDULIS SHELL - UNII:49OY13BE7Z) OSTREA EDULIS SHELL 8 [hp_X] in 1 g SUS SCROFA SKIN (UNII: 3EM4VW6TQN) (SUS SCROFA SKIN - UNII:3EM4VW6TQN) SUS SCROFA SKIN 8 [hp_X] in 1 g SUS SCROFA UMBILICAL CORD (UNII: 118OYG6W3H) (SUS SCROFA UMBILICAL CORD - UNII:118OYG6W3H) SUS SCROFA UMBILICAL CORD 8 [hp_X] in 1 g BOS TAURUS SOMATIC NERVE (UNII: N1R7LRU866) (BOS TAURUS SOMATIC NERVE - UNII:N1R7LRU866) BOS TAURUS SOMATIC NERVE 8 [hp_X] in 1 g TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 8 [hp_X] in 1 g BOS TAURUS PLACENTA (UNII: 83AL37E3A7) (BOS TAURUS PLACENTA - UNII:83AL37E3A7) BOS TAURUS PLACENTA 11 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) ROSEMARY OIL (UNII: 8LGU7VM393) SODIUM HYDROXIDE (UNII: 55X04QC32I) TEA TREE OIL (UNII: VIF565UC2G) SAGE OIL (UNII: U27K0H1H2O) CITRUS PARADISI SEED (UNII: 12F08874Y7) GLYCERIN (UNII: PDC6A3C0OX) LAVENDER OIL (UNII: ZBP1YXW0H8) SORBIC ACID (UNII: X045WJ989B) WATER (UNII: 059QF0KO0R) SODIUM ALGINATE (UNII: C269C4G2ZQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-8375-5 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(48951-8375)
