Label: BLUE-EMU LIDOCAINE PAIN RELIEF CREAM- lidocaine cream 4% cream
- NDC Code(s): 69993-350-03
- Packager: NFI, LLC
- 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 April 24, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
Do not use
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- on large areas of the body or on cut, irritated or swollen skin
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- on puncture wounds
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- for more than one week without consulting a doctor
When using this product
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- use only as directed. Read and follow all directions and warnings on this carton.
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- do not allow contact with the eyes
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- do not bandage or apply local heat (such as heating pads) to the area of use
- Directions
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Inactive Ingredients
acrylates acrylamide copolymer, aloe barbadensis leaf juice (aloe vera), allantoin, caprylic capric triglyceride, cetyl alcohol, dl-panthenol, dimethicone, ethylhexylglycerin, emu oil, glycerin, glyceryl stearate, mineral oil, phenoxyethanol, polyethylene glycol 100 stearate, polysorbate 80, polysorbate 85, sodium polycrylate, stearic acid, triethanolamine, tocopherol acetate (Vitamin E), water.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 77 g Tube Carton Label
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INGREDIENTS AND APPEARANCE
BLUE-EMU LIDOCAINE PAIN RELIEF CREAM
lidocaine cream 4% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69993-350 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055) PANTHENOL (UNII: WV9CM0O67Z) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EMU OIL (UNII: 344821WD61) GLYCERIN (UNII: PDC6A3C0OX) PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I) MINERAL OIL (UNII: T5L8T28FGP) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYSORBATE 85 (UNII: A7F3N56197) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALLANTOIN (UNII: 344S277G0Z) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69993-350-03 1 in 1 CARTON 03/01/2017 1 77 in 1 TUBE; 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 03/01/2017 Labeler - NFI, LLC (121681919) Establishment Name Address ID/FEI Business Operations Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals 081301372 MANUFACTURE(69993-350)