WELAHEAD BY WELMATE LIDOCAINE 5% ROLL-ON- lidocaine 5% solution

WelAhead by Welmate Lidocaine 5% Roll-on by

Drug Labeling and Warnings

WelAhead by Welmate Lidocaine 5% Roll-on by is a Otc medication manufactured, distributed, or labeled by OTC PHARM LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCl 5%

Purporse

Topical Analgesic

Use

Temporarily Relieves minor pain

Warnings

For external use only

Do not use

• on large areas of the body or on cut, irritated or swollen skin
• on puncture wounds
• for more than week without consulting a doctor

When using this product:

• use cnly as directed. Read and follow all directions and warnings on this carton
• do not allow contact with the eyes and mucous membranes
• do not bandage or apply a local heat (such as heating pads) to the area of use

Stop use and aska doctor if

• condition worsens
• skin reactions occur, such as rash, itching, redness, irritation, pain, and swelling
• symptoms persist for more than 7 days or clear up and occur again within a days

Flammable

• keep away from fire or flame

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

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WELAHEAD BY WELMATE LIDOCAINE 5% ROLL-ON 
lidocaine 5% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83833-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83833-101-03	90 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/01/2023

Labeler - OTC PHARM LLC (119131224)

Registrant - OTC PHARM LLC (119131224)