Label: PAIN RELIEF WELL AT WALGREENS- lidocaine hcl 4% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-3178-03, 0363-3178-06 - Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated February 19, 2018
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- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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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
- Directions
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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
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INGREDIENTS AND APPEARANCE
PAIN RELIEF WELL AT WALGREENS
lidocaine hcl 4% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3178 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: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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/30/2015 Labeler - Walgreens (008965063) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(0363-3178) , label(0363-3178)