FLEX24 PAIN- camphor, menthol cream

Flex24 Pain by

Drug Labeling and Warnings

Flex24 Pain by is a Otc medication manufactured, distributed, or labeled by Flex24, Inc.. Drug facts, warnings, and ingredients follow.

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, 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

conditions worsens or if symptoms persist for more than 7 days

Caution

• Discontinue use if there is redness or excessive irritation on skin
• Avoid contact with eyes
• Arthritis: If pain persists 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

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

Directions

• Adults and children 2 years of age and older: Apply to the affected area not more than 3 times daily
• Children under 2 years old: consult a doctor
• Tear and apply in a circle of 25 mm diameter 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

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 40B, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

PRINCIPAL DISPLAY PANEL

FLEX24

RECOVER NATURALLY

PAIN CREAM

SAMPLE PACK

NET wt. 0.14 oz (3.8g)

Dist: FLEX24, INC.

4020 GALT OCEAN DRIVE, STE. 1607

FORT LAUDERDALE, FL 33308

CALL TOLL FREE 844.4.FLEX24

NDC: 73218-001-01

INGREDIENTS AND APPEARANCE

FLEX24 PAIN 
camphor, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73218-001
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 g  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 FLOWER (UNII: OZ0E5Y15PZ)
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 (UNII: G0R4UBI2ZZ)
CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
LACTIC ACID (UNII: 33X04XA5AT)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
MELALEUCA ALTERNIFOLIA WHOLE (UNII: 976KV4FXYF)
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, D- (UNII: A7E6112E4N)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73218-001-01	3.8 g in 1 PACKET; Type 0: Not a Combination Product	09/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/29/2019

Labeler - Flex24, Inc. (117114024)