WELAHEAD BY WELMATE LIDOCAINE 5% ROLL-ON- lidocaine 5% solution 
OTC PHARM LLC

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WelAhead by Welmate Lidocaine 5% Roll-on 83833-101

Active Ingredient

Lidocaine HCl 5%

Purporse

Topical Analgesic

Use

Temporarily Relieves minor pain

Warnings

For external use only

Do not use

When using this product:

Stop use and aska doctor if

Flammable

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

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

Directions

Adults and children over 12 years:

apply a thin layer to affeced area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

Children 12 years and younger: ask a doctor

Inactive Ingrediants

purified water, ethyl alcohol, propylene glycol, polysorbate 20, triethanolamine, phenoxyethanol, ethylhexylglycerin,

potassium carbomer, aloe vera, glycerin, chonüoitin sulfate, glucosamine sulfate, methylsulfonylmethane

Label

WELAHEAD BY WELMATE LIDOCAINE 5% ROLL-ON 
lidocaine 5% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83833-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM CARBONATE (UNII: BQN1B9B9HA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83833-101-0390 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/01/2023
Labeler - OTC PHARM LLC (119131224)
Registrant - OTC PHARM LLC (119131224)

Revised: 12/2023
Document Id: 0b75e83e-8c7c-6247-e063-6294a90ac413
Set id: 0b75e83e-8c7b-6247-e063-6294a90ac413
Version: 1
Effective Time: 20231201
 
OTC PHARM LLC