Label: MUSCLE GEL 155-250- arnica montana, magnesium sulphuricum, rhus toxicodendron gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70113-021-35 - Packager: Homeopathic Services 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 September 5, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
Warnings:
- For external use only. Do not apply to eyes, broken skin.
- If pregnant or breast-feeding, ask a health professional before use.
- If swallowed, get medical help or contact a Poison Control Center right away.
- Do not use if you are allergic to Arnica montana and to any of the inactive ingredients.
- Use this product only as directed.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUSCLE GEL 155-250
arnica montana, magnesium sulphuricum, rhus toxicodendron gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70113-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 12 [hp_X] in 1 g MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE 12 [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 ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70113-021-35 100 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2016 Labeler - Homeopathic Services Inc. (079796951) Registrant - OHM PHARMA INC. (030572478) Establishment Name Address ID/FEI Business Operations OHM PHARMA INC. 030572478 manufacture(70113-021) , pack(70113-021) , label(70113-021)