Label: BETULA RHUS SPECIAL ORDER cream
- NDC Code(s): 48951-2114-5
- 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 14, 2018
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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
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INGREDIENTS AND APPEARANCE
BETULA RHUS SPECIAL ORDER
betula rhus special order creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-2114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA PUBESCENS BARK (UNII: 3R504894L9) (BETULA PUBESCENS BARK - UNII:3R504894L9) BETULA PUBESCENS BARK 2 [hp_X] in 1 g SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE 2 [hp_X] in 1 g FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS) (FILIPENDULA ULMARIA ROOT - UNII:997724QNDS) FILIPENDULA ULMARIA ROOT 2 [hp_X] in 1 g URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS 2 [hp_X] in 1 g BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID 3 [hp_X] in 1 g BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 4 [hp_X] in 1 g COLCHICUM AUTUMNALE WHOLE (UNII: W79255C628) (COLCHICUM AUTUMNALE WHOLE - UNII:W79255C628) COLCHICUM AUTUMNALE WHOLE 5 [hp_X] in 1 g FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5) FORMICA RUFA 10 [hp_X] in 1 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 12 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength TEA TREE OIL (UNII: VIF565UC2G) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LAVENDER OIL (UNII: ZBP1YXW0H8) CETYL ALCOHOL (UNII: 936JST6JCN) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) XANTHAN GUM (UNII: TTV12P4NEE) SORBIC ACID (UNII: X045WJ989B) FRANKINCENSE OIL (UNII: 67ZYA5T02K) MYRRH OIL (UNII: H74221J5J4) CITRUS PARADISI SEED (UNII: 12F08874Y7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-2114-5 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(48951-2114)