Label: BITE RELIEF SCHERER LABS- benzocaine - 5.00% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64048-7336-2 - Packager: Product Quest Mfg.
- 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 March 29, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients Purpose
- PURPOSE
- Uses
- WarningFor external use only
- KEEP OUT OF REACH OF CHILDREN
- Direction
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Inactive ingredients
Acrylates/Dimethicone Copolymer
BHT
Bisabolol
C12-15 Alkyl Benzoate
Capryloyl Glycine
Caprylyl Glycol
Cedrus Atlantica Bark Extract
Cetyl Dimethicone
Chlorphenesin
Cinnamomum Zeylanicum Bark Extract
Cyclopentasiloxane
Disodium EDTA
Ethylhexyl Stearate
Ethylhexylglycerin
Glycerin
Hydrated Silica
Mannan
Neopentyl Glycol Diheptanoate
Phenoxyethanol
Polyester-7
Polyester-8
Portulaca Oleracea Extract
Propylene Glycol
Sarcosine
Sodium Polyacrylate
Steareth-100
Steareth-2
Styrene/Acrylates Copolymer
Trideceth-6
Water
Xanthan Gum - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BITE RELIEF SCHERER LABS
benzocaine - 5.00% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64048-7336 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) Benzocaine 5 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) PEG-2 Stearate (UNII: 94YQ11Y95F) ALCOHOL (UNII: 3K9958V90M) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Hydrocortisone (UNII: WI4X0X7BPJ) Methylparaben (UNII: A2I8C7HI9T) ALOE VERA LEAF (UNII: ZY81Z83H0X) Propylparaben (UNII: Z8IX2SC1OH) CHAMOMILE (UNII: FGL3685T2X) Propylene Glycol (UNII: 6DC9Q167V3) Diazolidinyl Urea (UNII: H5RIZ3MPW4) EDETATE DISODIUM (UNII: 7FLD91C86K) OLIVE OIL (UNII: 6UYK2W1W1E) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) Menthol (UNII: L7T10EIP3A) Peppermint (UNII: V95R5KMY2B) CLOVE OIL (UNII: 578389D6D0) Papain (UNII: A236A06Y32) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64048-7336-2 1 in 1 CARTON 02/10/2012 1 52 mL 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 02/10/2012 Labeler - Product Quest Mfg. (927768135) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(64048-7336) , label(64048-7336)