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Bioaches Package Insert

Status:
Prescription (Rx) Facts
Strength:
0.0375 g, 5 g
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Bioaches

DESCRIPTION:

Bioaches Patch contains capsaicin and menthol in a localized dermal delivery system. The capsaicin in Bioaches Patch is a synthetic equivalent of the naturally occurring compound found in chili peppers. Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very slightly soluble in water. The menthol is slightly soluble in water.

Bioaches Patch is a single-use patch stored in a foil pouch. Each Bioaches Patch is 7.6 cm x 12.7 cm (97 cm²) and consists of a polyester backing film coated with a drug-containing silicone adhesive mixture, and covered with a removable polyester release liner.

The empirical formula for capsaicin is C H NO , with a molecular weight of 305.42. The chemical compound capsaicin [(E)-8-methyl-N-vanillyl-6-nonenamide] is an activating ligand for transient receptor potential vanilloid 1 receptor (TRPV1) and it has the following structure:

The empirical formula for menthol is C H O, with a molecular weight of 156.27. The chemical compound menthol [(1R,2S,5R)-2-isopropyl-5-methylcyclohexanol ] is an activating ligand for transient receptor potential cation channel subfamily M member 8 (TRPM8). It has the following structure:

Each Bioaches Patch contains 0.0375% capsaicin (0.0375 grams of capsaicin per patch) and 5.00% menthol (5 grams of menthol per patch).

INDICATIONS AND USAGE

Bioaches Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Bioaches Patch is an external analgesic/counterirritant.

CONTRAINDICATIONS

Bioaches Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS

  • For external use only.
  • Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.
  • Consult physician for children under 12.
  • Do not use if you are allergic to Menthol.
  • Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days or rash, itching or excessive skin irritation occurs.
  • KEEP OUT OF REACH OF CHILDREN

DOSAGE AND ADMINISTRATION

Bioaches patch contains 0.0375% capsaicin and 5.00% menthol

Instructions for Use

Clean and dry affected area

Tear open pouch. Unseal bag and remove patch

Remove protective film and apply directly to area of pain

Apply to affected area not more than 3 times daily

Wash hands with soap after applying patch

Reseal pouch containing unused patches

Directions

Adults and children 12 years and over
  • apply to affected area
  • change patch 1 to 2 times daily
Children under 12 years
  • consult physician before use

Inactive Components: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodium Salt, Glycerin, lodopropynyl Butyl carbamate, Methylparaben, Polysorbate 80, Propylparaben. Sodium Polyacrylate and Water.

HOW SUPPLIED

Bioaches patch is supplied as

Box of 15 patchs: 3 pouches each containing 5 patches

Box of 1 patch: 1 Pouch in one Box

Box of 30 patches: 6 pouches each containing 5 patches.

Storage: Store below 25°C. Avoid direct sunlight.

Rx only

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Bioaches

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredients Capsaicin 0.0375 g, Menthol 5 g
Dosage form Patch
Route Topical
Marketing status not in the current FDA NDC Directory
Company (applicant) BIO-SANTEE CHEM
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.0375 g, 5 g – 5 in 1 pouch / 3 in 1 box NDC 69490-020-15
0.0375 g, 5 g – 1 in 1 pouch / 1 in 1 box NDC 69490-020-01
0.0375 g, 5 g – 5 in 1 pouch / 6 in 1 box NDC 69490-020-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.