Label: BITE AND STING RELIEF- benzocaine - 5.00% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-718-02 - Packager: Top care
- 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 July 9, 2018
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- 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
Water
PEG-2 Stearate
PEG-2 Stearate SE
SD Alcohol 40
Polyethylene
Hydrocortisone
Methylparaben
Aloe Barbadensis Leaf Extract
Propylparaben
Chamomilla Recutita (Matricaria) Flower Extract
Propylene Glycol
Diazolidinyl Urea
Disodium EDTA
Olea Europaea (Olive) Fruit Oil
Camphor
Menthol
Mentha Piperita (Peppermint) Oil
Eugenia Caryophyllus (Clove) Flower Oil
Papain - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BITE AND STING RELIEF
benzocaine - 5.00% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-718 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 g 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:36800-718-02 1 in 1 CARTON 08/06/2012 1 50 g 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 08/06/2012 Labeler - Top care (006935977) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(36800-718) , label(36800-718)