FLEXIGEN- menthol 1.25% cream 
Derma Care Research Labs, LLC

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Flexigen, Menthol 1.25%

Menthol 1.25%


Pain Relieving Cream

For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.

For external use only. Do not use with other topical pain relievers, with heating pads or heating devices. When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

If swallowed, get medical help or contact a Poison Control Center right away.

Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Aloe Barbadensis Leaf Extract, Boswellia Carterii Oil, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Citrus Sinensis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Dimethicone, Disodium EDTA, Ethylhexylglyerin, Glycerin, Glyceryl Stearate SE, Hydrolyzed Rice Protein, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polysorbate 60, Sesamum Indicum (Sesame) Seed Oil, Stearyl Alcohol, Tocopherol, Water, Xanthan Gum.

If pregnant or breast-feeding, ask a health professional before use.

Label

LABEL

FLEXIGEN 
menthol 1.25% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-371
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
SHEA BUTTER (UNII: K49155WL9Y)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
RICE BRAN (UNII: R60QEP13IC)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CHAMOMILE (UNII: FGL3685T2X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SESAME OIL (UNII: QX10HYY4QV)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ORANGE PEEL (UNII: TI9T76XD44)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DIMETHICONE 200 (UNII: RGS4T2AS00)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-371-0395 mL in 1 BOTTLE; Type 0: Not a Combination Product07/11/2022
2NDC:72839-371-015 mL in 1 BOTTLE; Type 0: Not a Combination Product07/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/11/2022
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)

Revised: 1/2024
Document Id: 0f0164f7-b392-1bfd-e063-6394a90a3ca0
Set id: e9ae2682-59b4-e796-e053-2995a90af921
Version: 2
Effective Time: 20240115
 
Derma Care Research Labs, LLC