WORKVIE

Drug Labeling and Warnings

Drug Details [pdf]

WORKVIE ROLL ON- lidocaine hcl, menthol cream 
Marketites 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.

----------

WORKVIE

DRUG FACTS

Active ingredients and Purpose

Active ingredientsPurpose
Lidocaine HCL 4%............................Topical analgesic
Menthol 1%.......................................Topical analgesic

Use

For the temporary relief of pain.

Warnings

For external use only. Avoid contact with the eyes.

Do not use

in large quantities, particularly over raw surfaces, or blistered areas.

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

children under 2 years of age: consult a doctor

Other information

▪ store in a cool dry place between (59-86°F)15-30°C

▪ don’t use if seal over cap is broken, torn, or missing

Inactive ingredients

aloe vera leaf, alpha-tocopherol, arnica montana flower, caprylhydroxamic acid, caprylyl glycol, cyclomethicone 5, dimethicone, dimethyl sulfone, glycerin, glyceryl monostearate, glycol stearate, methylpropanediol, PEG-100 stearate, PEG/PPG-18/18-dimethicone, phenoxyethanol, sodium lauryl sulfate, sodium polyacrylate, stearyl alcohol, sweet almond oil, trideceth-6, water

Questions or comments?

+1-305-800-1446 (M-F) 9 A.M. - 5 P.M. EST or www.workvie.com

Distributed by:

Marketites LLC

Coral Gables, FL 33134

Principal Display Panel

work vie

LIDOCAINE HCL 4%

INSTANT

PAIN

RELIEVING

ROLL ON

Topical Analgesic Cream

+Menthol 1% & Arnica

Maximum Strength

Paraben & Dye Free

2.5 oz. (71 g) Workvie Label

WORKVIE ROLL ON 
lidocaine hcl, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72393-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
ALMOND OIL (UNII: 66YXD4DKO9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72393-201-2571 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/201802/28/2019
Labeler - Marketites LLC (036140212)

Revised: 9/2019
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.