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NDC 27854-0400-01 Flanax Liniment .025; 10; 28 g/100g; g/100g; g/100g Details
Flanax Liniment .025; 10; 28 g/100g; g/100g; g/100g
Flanax Liniment is a TOPICAL LINIMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Belmora Llc. The primary component is CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.
Product Information
| NDC | 27854-0400 |
|---|---|
| Product ID | 27854-400_954a3d27-8e72-47ac-9f07-055a493635af |
| 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 | Flanax Liniment |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Methyl Salicylate, Menthol, Capsaicin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LINIMENT |
| Route | TOPICAL |
| Active Ingredient Strength | .025; 10; 28 |
| Active Ingredient Units | g/100g; g/100g; g/100g |
| Substance Name | CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE |
| Labeler Name | Belmora 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 27854-0400-01 (27854040001)
| NDC Package Code | 27854-400-01 |
|---|---|
| Billing NDC | 27854040001 |
| Package | 1 TUBE in 1 CARTON (27854-400-01) / 30 g in 1 TUBE |
| Marketing Start Date | 2020-09-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e159d8ae-57c5-4a7a-ba1a-780436b46360 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings: For external use only. Do not use if you are allergic to any of the active or inactive ingredients. Do not use: on wounds damaged,
broken, or irritated skin. With a heating pad. Immediately before or after taking a bath or shower. Stop use and ask a doctor if: Condition
worsens. Symptoms persist for more than 7 days or clear up and occur again within a few days. Skin irritation occurs. When using this
product, do not: heat, microwave, add to hot water or any container with heating water. May cause splattering and result in burns. Avoid
contact with lips, eyes, nose and any mucous membranes at all times. Do not bandage.
SPL UNCLASSIFIED SECTION
Directions: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily. A temporary burning may
be felt when applied, but usually disappears with continued use. Wash hands thoroughly after use to avoid spreading liniment to the eyes or other
sensitive areas of the body. If applying liniment to the hands wait 30 minutes before washing hands. Initial pain relief is usually noted within 1-2
weeks. If condition does not improve in 4 weeks discontinue use of this product. Children under 12 years of age: consult doctor before use.
SPL UNCLASSIFIED SECTION
Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Glyceryl Stearate, Peg-100 Stearate, Cetearyl Alcohol
and Polysorbate 60, Propylene Glycol, Stearyl Alcohol, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Hydroxypropyl
Methyl Cellulose, Acrylates/C10-30alkyl Acrylate Crosspolymer, Salix Alba (Willow) Bark Extract, Zingiber Officinale (Ginger) Root Extract,
Gaultheria Procumbens (Wintergreen) Leaf Extract, Zanthoxylum Americanum Bark Extract, Pinus Pinaster Bark/Bud Extract, Boswellia
Serrata Gum
SPL UNCLASSIFIED SECTION
Triple Action Pain Relief
Analgesic, Anesthetic and Anti-inflammatory Muscular Liniment
TORCEDURAS / SIMPLE BACK PAIN • ARTHRITIS • BRUISES • SPRAINS • STRAINS
WWW.FLANAXUSA.COM
Questions/Comments?
Distributed by Belmora LLC
2011 Crystal Dr. Suite 400
Arlington, VA 22202
1-888-799-2877 www.flanaxusa.com
INGREDIENTS AND APPEARANCE
| FLANAX LINIMENT
methyl salicylate, menthol, capsaicin liniment |
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| Labeler - Belmora Llc (112753244) |