LIDOCAINE PAIN RELIEF ROLL-ON- lidocaine 4% liquid

Lidocaine Pain Relief Roll-On by

Drug Labeling and Warnings

Lidocaine Pain Relief Roll-On by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: consult a doctor.

INACTIVE INGREDIENT

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylparaben, polysorbate 60, SD alcohol 40 (15%), steareth-2, steareth-21, water

ACTIVE INGREDIENT

Lidocaine 4%

WARNINGS

For External Use Only.

When using this product:

use only as directed

do not bandage tightly or use with a heating pad

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

INDICATIONS & USAGE

For temporarily relief of pain and itching.

PURPOSE

Topical analgesic

CVS Label

Equate Label

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEF ROLL-ON 
lidocaine 4% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-9130
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-9130-97	1 in 1 CARTON	06/05/2019
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	06/05/2019

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(0395-9130) , analysis(0395-9130) , label(0395-9130) , pack(0395-9130)