Label: SPORTS FORMULA (arnica (a. montana) tinc, hemp extract- cannabis sativa 1x lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76524-301-02 - Packager: PROTEGE' MEDIA LLC
- Category: HUMAN OTC DRUG LABEL
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 8, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients Purpose
- PURPOSE
- Indication:
- KEEP OUT OF REACH OF CHILDREN
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Warnings:
• For external use only. Not for use on open wounds.
• If symptoms persist or worsen, discontinue use, seek medical attention.
• Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.
• If rash, redness, irritation or itching occurs, discontinue use.
• If pregnant or breastfeeding ask a health professional before use.
• If diagnosed with psychiatric or mood disorder, seek medical advice before use.
• If swallowed, get medical help or contact a Poison Center.
• Keep out of reach of children. -
Directions For Use:
- Liberally apply gel to affected area and rub into joints.
- Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort.
- Use no more than 4 times per day.
- Allow several days for product to take maximum effect.
- Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)
- Other Information:
- Inactive Ingredients:
- Comments, Questions or Complaints?
- PRODUCT LABEL
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INGREDIENTS AND APPEARANCE
SPORTS FORMULA
arnica (a. montana) tinc, hemp extract (cannabis sativa) 1x lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76524-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER 70 mg in 1 mL CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D) (CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP - UNII:8X454SZ22D) CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP 15.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494) WATER (UNII: 059QF0KO0R) OLIVE OIL (UNII: 6UYK2W1W1E) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EDETATE SODIUM (UNII: MP1J8420LU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76524-301-02 56 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/28/2020 Labeler - PROTEGE' MEDIA LLC (117063923)