PAIN RELIEF ROLL-ON GOOD SENSE- lidocaine hcl gel
Good Sense

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

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

Uses For temporary relief of pain and itching

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

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 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.

Questions? 1-866-483-2846

image description

PAIN RELIEF ROLL-ON GOOD SENSE
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-774
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-774-03	74 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/15/2019

Labeler - Good Sense (076059836)

Registrant - Product Quest Mfg (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg		927768135	manufacture(50804-774) , label(50804-774)