LIDOCAINE PAIN RELIEF ROLL-ON- lidocaine 4% liquid

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 4%

PURPOSE

Topical analgesic

INDICATIONS & USAGE

For temporarily relief of pain and itching.

WARNINGS

For External Use Only.

When using this product:

use only as directed

do not bandage tightly

avoid contact with eyes

do not apply to wounds or damaged skin

do not use in large quantities partifcularly over raw surfaces or blistered areas

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within 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 immediately.

DOSAGE & ADMINISTRATION

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a doctor.

INACTIVE INGREDIENT

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf extract, aminomethyl propanol, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, cyclopentasiloxane (and) C30-45 alkyl cetearyl dimethicone crosspolymer, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, methylparaben, SD alcohol 40, steareth-21, purified water

QUESTIONS

1-833-551-0932

2026 Label

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEF ROLL-ON 
lidocaine 4% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82645-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARETH-21 (UNII: 53J3F32P58)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82645-013-97	1 in 1 CARTON	04/14/2026
1		74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/14/2026

Labeler - Pharma Nobis, LLC (118564114)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(82645-013) , analysis(82645-013) , label(82645-013) , pack(82645-013)