Label: THERAPEUTIC HERBAL MUSCLE CALM CAPSICUM- capsicum lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 30056-007-08 - Packager: Eco-Logics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 6, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
- Warnings
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When using this product
When using this product
- use only as directed
- do not bandage
- do not use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds, damaged, broken or irritated skin
- a transient burning sensation may occur upon application but generally disappears in several days
- if severe burning sensation occurs, discontinue use immediately
- do not expose the area treated with product to heat or direct sunlight
- Stop use and ask a doctor if
- If pregnant or breastfeeding
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Directions
Directions
adults and children over 18 years:
- apply to affected area
- massage into painful area until thoroughly absorbed
- repeat as necessary, but no more than 3 to 4 times daily
- WASH HANDS WITH SOAP AND WATER AFTER APPLYING
- children 18 years or younger: ask a doctor
Keep out of the reach of children.
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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Inactive Ingredients
Aqueous (Deionized Water) infusion of botanical extracts of Passiflora Incarnata, Arnica Montana, Ruscus Acluteatus, Hypericum Perforatum, Arctium Lappa, Anthemis Nobilis, *Aloe Barbadensis, Custom blend of *Helianthus annuus (Sunflower Oil),* Olea Europaea (Olive Oil), *Simmondsia Chinenesis (Jojoba Oil), *Linum Usitatissimum (Flax Seed Oil), Boswellia Serrata, Methylsulfonylmethane, Glycerin, Ceteareth-20, Cetyl Alcohol, Stearyl Alcohol, Juniperus Communis Oil, Origanum Marjorana Oil, Lavandula Officinalis Oil, Rosmarinus Officianalis Oil, Thymus Zygis Oil, Tocopherol (Vitamin E), Phenoxyethanol, Ethylhexylglycerin
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THERAPEUTIC HERBAL MUSCLE CALM CAPSICUM
capsicum lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30056-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum .25 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Ruscus Aculeatus Root (UNII: ZW12V95I1Q) Hypericum Perforatum (UNII: XK4IUX8MNB) Arctium Lappa Root (UNII: 597E9BI3Z3) Passiflora Incarnata Top (UNII: CLF5YFS11O) Arnica Montana (UNII: O80TY208ZW) Chamaemelum Nobile (UNII: 7NF3GE7IWR) Aloe Vera Leaf (UNII: ZY81Z83H0X) Sunflower Oil (UNII: 3W1JG795YI) Olive Oil (UNII: 6UYK2W1W1E) Jojoba Oil (UNII: 724GKU717M) Linseed Oil (UNII: 84XB4DV00W) Frankincense (UNII: R9XLF1R1WM) Dimethyl Sulfone (UNII: 9H4PO4Z4FT) Glycerin (UNII: PDC6A3C0OX) Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY) Cetyl Alcohol (UNII: 936JST6JCN) Stearyl Alcohol (UNII: 2KR89I4H1Y) Juniper (UNII: 464910T5N9) Sweet Marjoram Oil (UNII: ICH7BE016E) Lavender Oil (UNII: ZBP1YXW0H8) Rosemary Oil (UNII: 8LGU7VM393) Thyme Oil (UNII: 2UK410MY6B) Alpha-Tocopherol (UNII: H4N855PNZ1) Phenoxyethanol (UNII: HIE492ZZ3T) Ethylhexylglycerin (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30056-007-08 236 g in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/15/2010 Labeler - Eco-Logics, Inc. (047667022)
