ACTAFLEX- topical analgesic cream 
Nordic Clinical Center, LLC

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 Ingredient                          Purpose

Menthol (1.25%)…………………….Topical Analgesic

Uses temporary relieves of minor aches and pains of muscles and joints associated with · simple backaches · arthritis · strains · sprains · bruises

Uses temporary relieves of minor aches and pains of muscles and joints associated with · simple backaches · arthritis · strains · sprains · bruises

Warnings For external use only • Use only as directed

Do not use· with a heating pad, may blister skin · on open wounds or damaged skin

Ask a doctor before use if you have redness over the affected area

When using this product· Avoid contacts with eyes · Do not bandage tightly

Stop use and consult doctor if · skin redness or excessive skin irritation develops · condition worsens or symptoms persist for more than 7 days · symptoms clear up and occur again in a few days

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

Directions Apply generously to the area not more than 3-4 times daily. Children under 12 years of age: consult a doctor.

Other information Store in a cool, dry place.

Inactive ingredients Water, Celadrin® (Esterified Fatty Acid Complex (EFAC), Glycerin, Stearyl Alcohol, Glyceryl Stearate, Stearyl Phosphate, Polyacrylamide, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Olive Oil, C13-14 Isoparaffin, Laureth-7, Healianthus Annuus (Sunflower) Extract, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis Leaf Juice, Hexylene Glycol, Triethaolamine, Xanthan Gum, Tocopherol, Allantoin, Pantheno, Ethylhexyglycerin

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Drug Facts

Active Ingredient Purpose

   Menthol (1.25%)……………………Topical Analgesic

Uses temporary relieves of minor aches and pains of muscles and joints associated with · simple backaches · arthritis · strains · sprains · bruises

Warnings For external use only · Use only as directed

Do not use· with a heating pad, may blister skin · on open wounds or damaged skin

Ask a doctor before use if you have redness over the affected area

When using this product· Avoid contacts with eyes · Do not bandage tightly

Stop use and consult doctor if · skin redness or excessive skin irritation develops · condition worsens or symptoms persist for more than 7 days · symptoms clear up and occur again in a few days

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

Directions Apply generously to the area not more than 3-4 times daily. Children under 12 years of age: consult a doctor.

Other information Store in a cool, dry place.

Inactive ingredients Water, Celadrin® (Esterified Fatty Acid Complex (EFAC), Glycerin, Stearyl Alcohol, Glyceryl Stearate, Stearyl Phosphate, Polyacrylamide, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Olive Oil, C13-14 Isoparaffin, Laureth-7, Healianthus Annuus (Sunflower) Extract, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis Leaf Juice, Hexylene Glycol, Triethaolamine, Xanthan Gum, Tocopherol, Allantoin, Pantheno, Ethylhexyglycerin

Product Label
ACTAFLEX 
topical analgesic cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72145-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
STEARYL PHOSPHATE (UNII: F3C8G3904Y)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALOE (UNII: V5VD430YW9)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALLANTOIN (UNII: 344S277G0Z)  
PANTHENOL (UNII: WV9CM0O67Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72145-001-0157 g in 1 TUBE; Type 0: Not a Combination Product03/19/2018
2NDC:72145-001-0296.4 g in 1 TUBE; Type 0: Not a Combination Product03/19/201809/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/19/201809/26/2020
Labeler - Nordic Clinical Center, LLC (081012969)
Establishment
NameAddressID/FEIBusiness Operations
Genco Properties079916225manufacture(72145-001)

Revised: 7/2021
 
Nordic Clinical Center, LLC