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NDC 27854-0404-04 Flanax Liniment Unit Dose Display .025; 10; 28 g/100g; g/100g; g/100g Details

Flanax Liniment Unit Dose Display .025; 10; 28 g/100g; g/100g; g/100g

Flanax Liniment Unit Dose Display 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	27854-0404
Product ID	27854-404_eb98339b-6b89-4082-9609-38f08e214cd9
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 Unit Dose Display
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 27854-0404-04 (27854040404)

Pricing Information	N/A
NDC Package Code	27854-404-04
Billing NDC	27854040404
Package	4 g in 1 TUBE (27854-404-04)
Marketing Start Date	2022-02-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d8b51fa7-8511-42f5-b715-bd2ac0afcba5 Details

Drug Facts

Active Ingredients

Methyl Salicylate 28%

Menthol 10%

Capsaicin 0.025%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, strains and bruises.

Warnings:

For external use only.

Refer to display box for complete product information.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions:

Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily. Thoroughly wash hands after application.

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Glyceryl Stearate (and) Peg-100 Stearate, Cetearyl Alcohol and Polysorbate 60, Propylene Glycol, Stearyl Alcohol, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Hydroxypropyl Methyl Cellulose, Acrylates/C10-30 alkyl 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

Questions/Comments?

1888 779 2877

Belmora LLC, 3033 Wilson Blvd. Suite 700, Arlington, VA 22201

Packaging

INGREDIENTS AND APPEARANCE

FLANAX LINIMENT UNIT DOSE DISPLAY

methyl salicylate, menthol, capsaicin liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:27854-404
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	28 g in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 g in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SALIX ALBA BARK (UNII: 205MXS71H7)
GINGER (UNII: C5529G5JPQ)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)
MARITIME PINE (UNII: 50JZ5Z98QY)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:27854-404-04	4 g in 1 TUBE; Type 0: Not a Combination Product	02/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/15/2022

Labeler - Belmora LLC (112753244)

Revised: 2/2022

Document Id: eb98339b-6b89-4082-9609-38f08e214cd9

Set id: d8b51fa7-8511-42f5-b715-bd2ac0afcba5

Version: 1

Effective Time: 20220222