Flexilon by Topical Pharmaceuticals Inc. FLEXILON™ 

Flexilon by

Drug Labeling and Warnings

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

Drug Details [pdf]

FLEXILON- camphor, menthol, methyl salicylate cream 
Topical Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FLEXILON™ 

Drug Facts

Active Ingredients

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 again 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° - 25°C (68° - 77°F)

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

SEMPRAE™

ARTHRITIS RELIEF

Muscle Aches
Joint Pain Arthritis
Back Pain Knee Pain

If muscles or joint aches and pain slows you down, we would like to introduce you to Flexilon Arthritis Cream.
Flexilon is a fast-acting and powerful arthritis cream, formulated to target the joints where arthritis resides and soothe the pain for long lasting relief.
Flexilon over-the-counter medication cream provides ultra strength, deeper penetrating pain relief in muscles and joints.

Manufactured for: SEMPRAE™

Semprae Laboratories, Inc.

Englewood, CO 80112

For comments or questions and to place an order,
Call us at 1-800-996-5122 or visit us at www.myflexilon.com

Packaging

FLEXILON 
camphor, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15478-101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15478-101-14	1 in 1 CARTON	12/28/2020
1		56.7 g in 1 JAR; 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	12/28/2020

Labeler - Topical Pharmaceuticals Inc. (831530683)

Establishment
Name	Address	ID/FEI	Business Operations
Topical Pharmaceuticals Inc.		831530683	manufacture(15478-101)

Revised: 1/2021

Document Id: 7ebff913-78f6-4ffc-8e38-fda65604b797

34390-5

Set id: 8e531f12-9d8a-4fed-984a-0262848a45a0

Version: 3

Effective Time: 20210119