FLEX24 PAIN- camphor menthol cream

Drug Labeling and Warnings

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

Larasan Pharmaceutical Corp.

1287 E. Newport Center Drive, Suite 206

Deerfield Beach, FL 33442

Made in USA

54641-008-01

PRINCIPAL DISPLAY PANEL

Pain Cream

Pain Relief

• Long Lasting
• Invisible
• No smell

3.4 oz (96 g)

• Fast and Long-Lasting Pain Relief
• Smooth, Non-Sticky, Pleasant Smell
• Invsible Relief for Hours

Flex24(r)

Recover Naturally

INGREDIENTS AND APPEARANCE

FLEX24 PAIN 
camphor menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54641-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3   in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54641-008-01	96 g in 1 CONTAINER; Type 0: Not a Combination Product	02/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/22/2019

Labeler - Larasan Pharmaceutical Corporation (078350375)

Establishment
Name	Address	ID/FEI	Business Operations
Dong E E Hua Medical Technology Co., Ltd.		527813247	manufacture(54641-008)