Label: PAIN RELIEF EQUATE- lidocaine hcl 4% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-287-03 - Packager: Walmart
- 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 December 29, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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 persist for more than 7 days or clear up and occur again within
a few days - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
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 EQUATE
lidocaine hcl 4% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-287 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 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) STEARETH-21 (UNII: 53J3F32P58) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-287-03 1 in 1 CARTON 05/29/2017 1 74 mL in 1 BOTTLE; 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 05/29/2017 Labeler - Walmart (051957769) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(49035-287) , label(49035-287)