THERAPEUTIC HERBAL MUSCLE CALM CAPSICUM- capsicum lotion

Therapeutic Herbal Muscle Calm by

Drug Labeling and Warnings

Therapeutic Herbal Muscle Calm by is a Otc medication manufactured, distributed, or labeled by Eco-Logics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                  Purpose

Capsicum .025%                                                 Topical Analgesic

Uses

Uses Temporarily relieves minor pain of muscles and joints associated with:

• arthritis
• simple back ache
  
• strains
• bruises
  

Warnings

Warnings For external use only.

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

Stop use and ask a doctor

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• irritation develops
  

If pregnant or breastfeeding

If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.

If swallowed, get medical help or contact a Poison  Control  Center  right away.

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.

Directions

Directions

Adults and children 2 years of age and older:

• Apply to painful muscles and joint. Gently massage thoroughly into affected area.
• Repeat as necessary but not more than 4 times daily.
  

Purpose

Active Ingredients                                   Purpose

Capsicum .025%.............................. Topical Analgesic

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

INGREDIENTS AND APPEARANCE

THERAPEUTIC HERBAL MUSCLE CALM  CAPSICUM
capsicum lotion

Product 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)