PAIN RELIEF ROLL-ON- lidocaine hcl gel

Pain Relief Roll-on by

Drug Labeling and Warnings

Pain Relief Roll-on by is a Otc medication manufactured, distributed, or labeled by Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                              Purpose
Lidocaine HCl 4%..............................................Topical anesthetic

PURPOSE

INDICATIONS & USAGE

Uses For temporary relief of pain and itching

WARNINGS

Warnings
For external use only.
When using this product use only as directed avoid contact with eyes 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

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

DOSAGE & ADMINISTRATION

Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

INACTIVE INGREDIENT

Inactive ingredients
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, Methylparaben, SD
Alcohol 40, Steareth-21, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF ROLL-ON 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64048-3333
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Ceteth-20 Phosphate (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
Dimethicone (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Ethylhexylglycerin (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Methylparaben (UNII: A2I8C7HI9T)
ALCOHOL (UNII: 3K9958V90M)
Steareth-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64048-3333-3	74 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2017

Labeler - Product Quest Mfg (927768135)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(64048-3333) , label(64048-3333)