PAIN RELIEF ROLL-ON- lidocaine 4% liquid

pain relief roll-on by

Drug Labeling and Warnings

pain relief roll-on by is a Otc medication manufactured, distributed, or labeled by Bionpharma Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical analgesic

Uses

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, particularly 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.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

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 ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, polysorbate 60, SD Alcohol 40, Steareth-21, Purified Water

Carton Label

*compare to the active ingredient

in Aspercreme® Odor Free

with 4 % Lidocaine

NDC: 69452-393-63

a+health™

maximum strength

pain relief

roll-on

lidocaine 4% HCl/

topical analgesic

odor free

no mess applicator

• temporarary relief of pain
• helps pain-affected areas

without irritation

2.5 fl oz (74mL)

with aloe

INGREDIENTS AND APPEARANCE

PAIN RELIEF ROLL-ON 
lidocaine 4% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-393
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: 69452-393-63	1 in 1 CARTON	02/20/2023
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	02/20/2023

Labeler - Bionpharma Inc. (079637826)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(69452-393) , analysis(69452-393) , label(69452-393) , pack(69452-393)