ANALGESIC- lidocaine hydrochloride gel

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Lidocaine

HCl 2.0%

Purpose

Topical

pain relief

Uses

Temporary pain relief for minor burns

Warnings

External use only. Keep out of reach of children.

Do not use

• near eyes, if this happens, rinse thoroughly with water
• in large quantities, particularly over raw or blistered areas

Stop use, ask a doctor

• if conditions worsen or last more than 7 days or clears up and returns. If ingested contact a Poison Control Center directly

Directions

• adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
• children under 2: do not use, ask a doctor

Inactive ingredients

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Principal Display Panel - Welly Health Burn Gel Pouch Label

Welly™

Burn Gel

0.9/ 1/32 OZ

INGREDIENTS AND APPEARANCE

ANALGESIC 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72663-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	2 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
carboxypolymethylene (UNII: 0A5MM307FC)
diazolidinyl urea (UNII: H5RIZ3MPW4)
menthol, unspecified form (UNII: L7T10EIP3A)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)
.alpha.-tocopherol, d- (UNII: N9PR3490H9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-500-04	0.9 mL in 1 POUCH; Type 0: Not a Combination Product	02/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/25/2019

Labeler - Welly Health PBC (116766884)