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NDC 59316-0004-01 Biofreeze Flexible Relief Strip 56 mg/g Details
Biofreeze Flexible Relief Strip 56 mg/g
Biofreeze Flexible Relief Strip is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is MENTHOL, UNSPECIFIED FORM.
Product Information
| NDC | 59316-0004 |
|---|---|
| Product ID | 59316-004_cefc6ed9-1763-44cd-a74e-52a1b8b7d704 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Biofreeze Flexible Relief Strip |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | MENTHOL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PATCH |
| Route | TOPICAL |
| Active Ingredient Strength | 56 |
| Active Ingredient Units | mg/g |
| Substance Name | MENTHOL, UNSPECIFIED FORM |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 59316-0004-01 (59316000401)
| NDC Package Code | 59316-004-01 |
|---|---|
| Billing NDC | 59316000401 |
| Package | 1 PATCH in 1 POUCH (59316-004-01) / 6 g in 1 PATCH |
| Marketing Start Date | 2021-03-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6ec26bae-e395-49aa-969e-8c653d6f0b27 Details
Uses
Warnings
For external use only.
When using this product
- use only as directed
- avoid contact with the eyes or on mucous membranes
- do not apply to wounds or damaged skin
- do not apply to irritated skin or if excessive irritation develops
- do not bandage tightly or use with heating pad or device
Directions
- adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on affected area not more than 3 to 4 times daily.
- do not stretch the patch during application as it should be comfortable and not tight
- do not overwrap or wrap patches over themselves
- for best adhesion: area should be clean, dry, and smooth
- children under 12 years of age: consult a physician
- wash hands after use with cool water
Inactive ingredients
Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Benzalkonium Chloride, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Isopropyl Myristate, Kaolin, L-Tartaric Acid, Lauralkonium Chloride, Mineral Oil, Nonoxynol-10, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium Dioxide, Water
PRINCIPAL DISPLAY PANEL - 4 Strip Carton
CLINICALLY
RECOMMENDED*
NDC 59316-004-04
BiOFREEZE®
COOL THE PAIN
FLEXIBLE
RELIEF
STRIPS
MENTHOL-PAIN
RELIEVING PATCH
Designed to provide up to
8 hours of long lasting
pain relief
Strong adhesion to stay
through any movement
Optimal thickness for
comfort and flexiblity
4 STRIPS |
EXTRA
LONG
10 in x 2 in
(25.4 cm x 5 cm) each
INGREDIENTS AND APPEARANCE
| BIOFREEZE FLEXIBLE RELIEF STRIP
menthol patch |
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| Labeler - RB Health (US) LLC (081049410) |
Revised: 1/2022
Document Id: cefc6ed9-1763-44cd-a74e-52a1b8b7d704
Set id: 6ec26bae-e395-49aa-969e-8c653d6f0b27
Version: 3
Effective Time: 20220120