Label: MELISSA cream
- NDC Code(s): 48951-7203-1
- 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 January 31, 2024
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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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 or if conditions worsen or persist. 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
MELISSA
melissa creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-7203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 30 [hp_X] in 1 g MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS 1 [hp_X] in 1 g ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 30 [hp_X] in 1 g ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength MYRRH OIL (UNII: H74221J5J4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) SORBIC ACID (UNII: X045WJ989B) TEA TREE OIL (UNII: VIF565UC2G) CITRUS PARADISI SEED (UNII: 12F08874Y7) FRANKINCENSE OIL (UNII: 67ZYA5T02K) CETYL ALCOHOL (UNII: 936JST6JCN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-7203-1 10 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(48951-7203)