ACTAFLEX- topical analgesic cream

Actaflex by

Drug Labeling and Warnings

Actaflex by is a Otc medication manufactured, distributed, or labeled by Nordic Clinical Center, LLC, Genco Properties. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                          Purpose

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

PURPOSE

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

INDICATIONS & USAGE

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

WARNINGS

Warnings For external use only Use only as directed

DO NOT USE

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

ASK DOCTOR

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

WHEN USING

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

STOP USE

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

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information Store in a cool, dry place.

INACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

ACTAFLEX 
topical analgesic cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72145-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72145-001-01	57 g in 1 TUBE; Type 0: Not a Combination Product	03/19/2018
2	NDC: 72145-001-02	96.4 g in 1 TUBE; Type 0: Not a Combination Product	03/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/19/2018

Labeler - Nordic Clinical Center, LLC (081012969)

Establishment
Name	Address	ID/FEI	Business Operations
Genco Properties		079916225	manufacture(72145-001)