Biosavia External Analgesic Pain Relief Gel

Biosavia External Analgesic Pain Relief Gel
SPL v1
SPL
SPL Set ID 814aa66b-7719-4a29-a84e-18290367e9c7
Route
TOPICAL
Published
Effective Date 2024-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.25 mg)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Whole Carbomer Homopolymer, Unspecified Type Orange Oil, Cold Pressed Dmdm Hydantoin Glycerin Isopropyl Myristate Peppermint Oil Mineral Oil Asian Ginseng Peg-12 Dimethicone Polyoxyl 40 Hydrogenated Castor Oil Fd&c Red No. 40 Sodium Hydroxide Edetate Sodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-19

Description

Capsaicin 0.025 %

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.025 %

Uses

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

  • strains
  • bruises
  • sprains
  • arthritis
  • simple neck or back ache
Do Not
  • use on wounds or damaged skin
  • use if you are allergic to any ingredients in this product
Warnings

For external use only

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
Drug Facts

Questions?

(954) 588-9852

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)

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

Active Ingredients

Capsaicin 0.025 %

When Using This Product
  • Avoid contact with the eyes
Keep Out Reach of Children

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


Structured Label Content

Uses

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

  • strains
  • bruises
  • sprains
  • arthritis
  • simple neck or back ache
Do Not (Do not)
  • use on wounds or damaged skin
  • use if you are allergic to any ingredients in this product
Purpose

Topical Analgesic

Warnings

For external use only

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
Drug Facts

Questions?

(954) 588-9852

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)

Other Information (Other information)
  • Store between 20-25C (68-77 F)
  • store in a cool dry place away from direct sun light
Package Labeling:

Active Ingredients (Active ingredients)

Capsaicin 0.025 %

When Using This Product (When using this product)
  • Avoid contact with the eyes
Keep Out Reach of Children (keep out reach of children)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms persist or get worse after than 7days
  • swallowed
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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