FLEXILON- methyl salicylate, menthol, camphor cream

Flexilon by

Drug Labeling and Warnings

Flexilon by is a Otc medication manufactured, distributed, or labeled by Semprae Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor 4%

Menthol 7.5%

Methyl Salicylate 10%

PURPOSE

Topical analgesic

USES

For the temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

For external use only

Do not use

• on wounds or damaged , broken or irritated skin 
• with a heating pad

When using this product

• avoid contact with eyes or mucous membranes 
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens 
• you have redness over the affected area 
• symptoms persist for more than 7 days or symptoms clear up and occur within a few days 
• excessive skin irritation occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Center immediately

DIRECTIONS

• use only as directed 
• Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 12 years of age: consult a doctor.

OTHER INFORMATION

store at 20-25C (68-77F)

Do not purchase if outer seal is broken

INACTIVE INGREDIENTS

carbomer, cetearyl alcohol, D.I. water, FD&C Blue no. 1, FD&C Yellow no.5, glucosamine sulfate, glyceryl monostearate, methyl sulfonyl methane,
methylparaben, mineral oil 90, PEG-100, propylparaben, polysorbate 60, stearyl alcohol, triethanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEXILON 
methyl salicylate, menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72826-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.5 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72826-101-14	1 in 1 CARTON	11/10/2020
1		56.7 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/10/2020

Labeler - Semprae Laboratories Inc (093739668)

Registrant - Semprae Laboratories Inc (093739668)