Label: WOUND HEALING- calendula officinalis cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76029-003-35 - Packager: Active Release Techniques
- 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 March 30, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Argania Spinosa Kernel Oil, Betula Alba Bark Extract, Cetearyl Olivate, Chlorphenesin, Citric Acid, Copernicia Cerifera (Carnauba) Wax, Dromiceius, Ethoxydiglycol, Glycerin, Hippophae Rhamnoides Oil, Isopropyl Palmitate, Leptospermum Scoparium Oil, Porphyridium Cruentum Extract, Potassium Citrate, Rutin, Sambucus Nigra Flower Extract, Scrophularia Nodosa Extract, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Water/Aqua, Xanthan Gum
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INGREDIENTS AND APPEARANCE
WOUND HEALING
calendula officinalis creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76029-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_C] in 35 g Inactive Ingredients Ingredient Name Strength ARGAN OIL (UNII: 4V59G5UW9X) BETULA PUBESCENS BARK (UNII: 3R504894L9) CETEARYL OLIVATE (UNII: 58B69Q84JO) CHLORPHENESIN (UNII: I670DAL4SZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CARNAUBA WAX (UNII: R12CBM0EIZ) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3) PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N) POTASSIUM CITRATE (UNII: EE90ONI6FF) RUTIN (UNII: 5G06TVY3R7) SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) SCROPHULARIA NODOSA (UNII: 7H443NUB2T) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN OLIVATE (UNII: MDL271E3GR) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76029-003-35 35 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/20/2011 Labeler - Active Release Techniques (174462593) Registrant - Active Release Techniques (174462593) Establishment Name Address ID/FEI Business Operations Leo Desilets maitre herboriste Inc/Facotek Packaging 245423439 manufacture