Pain Relief Well At Walgreens (Lidocaine Hcl 4%) Cream [Walgreens] -

PAIN RELIEF WELL AT WALGREENS (LIDOCAINE HCL 4%) CREAM [WALGREENS]
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NDC	0363-3178-03, 0363-3178-06
Set ID	86360cb7-b1bf-49c0-be7a-d40ecfdc5e1d
Category	HUMAN OTC DRUG LABEL
Packager	Walgreens
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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Active ingredient Purpose

Lidocaine HCl 4% Topical Anesthetic
PURPOSE
Uses

temporarily reliefs minor pain associated with • arthritis • simple backache •muscle strains • bruises
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 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 WELL AT WALGREENS
lidocaine hcl 4% cream

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

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
Packaging
1	NDC:0363-3178-06	1 in 1 CARTON	07/30/2015
1		76.5 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0363-3178-03	1 in 1 CARTON	07/30/2015
2		71 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/30/2015

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg. (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg.		927768135	manufacture(0363-3178) , label(0363-3178)

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