PAIN RELIEF- lidocaine hcl cream

Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient                                               Purpose

Lidocaine HCl 4%                                              Topical Analgesic

PURPOSE

Uses

Uses For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritation

Warnings

​For external use only

When using this product 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 last more than 7 days or clear up and occur again within a few days

Keep out of reach of the children.

If product is swallowed, get medical help or contact a Poison Control Center right away

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 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, SD Alcohol 40, Steareth-21, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-740
Route of Administration	TOPICAL

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

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: 36800-740-03	77 g in 1 CONTAINER; Type 0: Not a Combination Product	11/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/17/2017

Labeler - Topco (006935977)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(36800-740) , label(36800-740)