FLEX24 PAIN- camphor menthol cream 
Larasan Pharmaceutical Corporation

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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Active Ingredients

Menthol, 10%
Camphor, 3%

Purpose

Topical analgesic

Uses

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

Warnings

For external use only

Do not

• Apply to open wounds, or damaged, broken, or irritated skin

Stop use and ask a doctor if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Caution

• Discontinue use if excessive irritation of the skin develops
• Avoid contact with the eyes and mucous membranes
• Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately.

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

Directions

• Adults and children 2 years of age or older: Apply to affected area as and when required.
• Remove the cap and apply in a circle of 25 mm diameter (size of a quarter) to affected area and spread smoothly over the skin with fingers.
• Wash fingers that applied cream with water. Do not rub eyes with fingers until washed with water.
• Children under 2 years old: consult a doctor

Inactive Ingredients

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aqua (Deionized water), Arnica Montana flower extract, Ascorbic Acid (Vitamin C), Beta Glucan, Boswellia Extract, Ceramide NG, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Distearyldimonium Chloride, Gluconolactone, Glyceryl Stearate, Glycerin, Helianthus Annuus (sunflower) oil, Lactic acid, Magnesium Sulfate, Melaleuca Alternifolia (Tea tree) oil, Xanathan Gum, Methylsulfonylmethane (MSM), PPG 12/SMD1 copolymer, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, SD-Alcohol 4013, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

Other Information

Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

Questions/Comments?

www.FLEX24.com/paincream

Larasan Pharmaceutical Corp.

1287 E. Newport Center Drive, Suite 206

Deerfield Beach, FL 33442

Made in USA

54641-008-01

Pain Cream

Pain Relief

3.4 oz (96 g)

Flex24(r)

Recover Naturally

20190218 54641_008_01

FLEX24 PAIN 
camphor menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54641-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3   in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA (UNII: O80TY208ZW)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
GLUCAN ENDO-1,3-.ALPHA.-GLUCOSIDASE AGN1 (UNII: 808D59AO7C)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
CERAMIDE NG (UNII: C04977SRJ5)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)  
CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LACTIC ACID, L- (UNII: F9S9FFU82N)  
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
TEA TREE OIL (UNII: VIF565UC2G)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
VITAMIN A (UNII: 81G40H8B0T)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
ALCOHOL (UNII: 3K9958V90M)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54641-008-0196 g in 1 CONTAINER; Type 0: Not a Combination Product02/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/22/2019
Labeler - Larasan Pharmaceutical Corporation (078350375)
Establishment
NameAddressID/FEIBusiness Operations
Dong E E Hua Medical Technology Co., Ltd.527813247manufacture(54641-008)

Revised: 2/2019
Document Id: 437c2b27-4ecb-4592-8cc9-6d72bfe35d19
Set id: 06f4e017-93d2-40fb-8965-93d9c2a915e7
Version: 1
Effective Time: 20190222
 
Larasan Pharmaceutical Corporation