SPORTS FORMULA- arnica (a. montana) tinc, hemp extract (cannabis sativa) 1x lotion 
PROTEGE' MEDIA LLC

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.

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Drug Facts

Active Ingredients                                                                                                    Purpose

Arnica (A. montana) Tinc. 7% (70mg)HPUS                                                           Analgesic
Hemp extract (Cannabis sativa) 1X 7% (15.7mg) HPUS                                          Anti-inflammatory

Approximately 56 applications per container

Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Indication:

Temporarily relieves pain associated with bruises, sore feet, muscle pain and strains

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:

Other Information:

• Consult a medical professional if using other medications for known interactions.
• Cannabidiol in hemp extract may alter the metabolism of other drugs.

Inactive Ingredients:

Ethylglycerin, C13-14 isoparaffin, laureth-7, phenoxyethanol, polyacrylamide, purified water, tetrasodium EDTA, virgin olive oil, vitamin E

Comments, Questions or Complaints?

Call 888-735-4009 or info@promedxnow.com

PRODUCT LABEL

image description

SPORTS FORMULA 
arnica (a. montana) tinc, hemp extract (cannabis sativa) 1x lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76524-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER70 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 TOP15.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76524-301-0256 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/28/2020
Labeler - PROTEGE' MEDIA LLC (117063923)

Revised: 1/2021
Document Id: b8689d00-25b8-535d-e053-2a95a90a30ae
Set id: 69ffcc27-1f87-4889-869b-209d48c3d15c
Version: 1
Effective Time: 20210108
 
PROTEGE' MEDIA LLC