Bio Healing by CharmGURU / Beone co., ltd

Bio Healing by

Drug Labeling and Warnings

Bio Healing by is a Otc medication manufactured, distributed, or labeled by CharmGURU, Beone co., ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIO HEALING- schorl tourmaline, menthol patch 
CharmGURU

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENTS

SCHORL Tourmaline (mg) : 3.182(S) / 7.128(M) / 22.761(L)
Menthol (mg) : 0.018(S) / 0.040(M) / 0.126(L)

INACTIVE INGREDIENTS

Styrene Isoprene Rubber, Hydrogenated Hydrocabon Resin, 1,2-Hexandiol, Silver Powder, Artemisia Princeps Extract, Capsicum Oleorrsin, Germanium Dioxide, 2Hydroxy Benzoic Acid, Glycerine

PURPOSE

Topical Analgesic

WARNINGS

For external use only
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Do not use
■ On wounds or damaged skin (can use in case of slight)
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Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients
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When using this product
■ Use only as directed ■ Read and follow all directions and warnings on this label ■ Do not allow contact with the eyes and mucous membranes or rashes ■ Discontinue use during hot steam baths
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Stop use and ask a doctor if
■ Condition worsens ■ Rash, itching or excessive skin irritation develops

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

For relief of aches and pains of muscles and joints associated with: ■ Arthritis ■ Bruises ■ Sprains ■ Spasm ■ Frozen shoulder ■ Menstrual pain ■ Itchy with Insect bites

Directions

Adult and children 12 years of age and over:
■ Clean and dry affected area ■ Peel film from patch and apply to the skin (see illustration) ■ Suggested duration of use for patch is 24 hours
Children under 12 years of age: Under the protection of parents
People with weak skin: Consult a physician

Other Information

■ Store at room temperature 50° to 104°F (10° to 40°C)
■ Store in a clean, dry place out of direct sunlight

Questions

■ Phone: +82-50-5233-7942, ■ WhatsApp: +82-10-4056-6761

NDC# 82541-020-02: Small size 24pcs (each 35.35mg)NDC# 82541-020-04: Medium size 12pcs (each 79.20mg) NDC# 82541-020-06: Large size 12pcs (each 252.90mg)

BIO HEALING 
schorl tourmaline, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82541-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SCHORL Tourmaline (UNII: 173O8XLY6T) (SCHORL Tourmaline - UNII:173O8XLY6T)	SCHORL Tourmaline	9.00 mg  in 100 mg
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	0.05 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
CAPSICUM OLEORESIN (UNII: UW86K581WY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ARTEMISIA PRINCEPS WHOLE (UNII: 2849G48V9J)
GERMANIUM DIOXIDE (UNII: 5O6CM4W76A)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82541-020-02	24 in 1 CARTON	10/01/2022	10/01/2023
1	NDC: 82541-020-01	35.35 mg in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 82541-020-04	12 in 1 CARTON	10/01/2022	10/01/2023
2	NDC: 82541-020-03	79.20 mg in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 82541-020-06	12 in 1 CARTON	10/01/2022	10/01/2023
3	NDC: 82541-020-05	252.90 mg in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2022	10/01/2023

Labeler - CharmGURU (695307109)

Registrant - CharmGURU (695307109)

Establishment
Name	Address	ID/FEI	Business Operations
Beone co., ltd		695578618	manufacture(82541-020)

Revised: 12/2023

Document Id: 3cf0e221-7ded-4d94-93fd-ec35f16eda51

34390-5

Set id: 0ed7738d-0e22-4422-bada-0d42664771a3

Version: 2

Effective Time: 20231220