BIOSAVIA EXTERNAL ANALGESIC PAIN RELIEF- capsaicin gel

BIOSAVIA External Analgesic Pain Relief by

Drug Labeling and Warnings

BIOSAVIA External Analgesic Pain Relief by is a Otc medication manufactured, distributed, or labeled by BIOSAVIA USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Capsaicin 0.025 %

Purpose

Topical Analgesic

Uses

Temporaryly relieves minor aches and pains of muscles and joints associated with

• strains
• bruises
• sprains
• arthritis
• simple neck or back ache

Warnings

For external use only

Do not

• use on wounds or damaged skin
• use if you are allergic to any ingredients in this product

When using this product

• Avoid contact with the eyes

Stop use and ask a doctor if

• symptoms persist or get worse after than 7days
• swallowed

If pregnant or breast-feeding,

ask a health professional before use

keep out reach of children

Directions

Adults and children 2 years of age and older apply liberally onto affected area not more than 3 to 4 times daily

• Massage evenly where needed until the gel is fully absorbed 
• Massage your feet for a better sleep
• For a craneal massage, use on your head from your neck to your temples pressing all over your scalp
• massage on afected area for physical fatigue, swollen feet and legs

Other information

• Store between 20-25C (68-77 F)
• store in a cool dry place away from direct sun light

Other Ingredients

Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, DMDM Hydantoin, Glycerin, Isopropyl Myristate, Mentha Piperita (Peppermint) Oil, Mineral Oil, Panax Ginseng Root Extract, PEG-12 Dimethicone, PEG-40 Hydrogenated Castor Oil, Red 40 (CI 16035), Sodium Hydroxide, Tetrasodium EDTA, Water (Aqua)

Questions?

(954) 588-9852

Package Labeling:

INGREDIENTS AND APPEARANCE

BIOSAVIA EXTERNAL ANALGESIC PAIN RELIEF 
capsaicin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84680-529
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEPPERMINT OIL (UNII: AV092KU4JH)
MINERAL OIL (UNII: T5L8T28FGP)
ASIAN GINSENG (UNII: CUQ3A77YXI)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84680-529-00	117.5 g in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/19/2024

Labeler - BIOSAVIA USA, LLC (119326193)