Label: ANTI-ITCH REGULAR STRENGTH- benzocaine and resorcinol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-0621-02 - Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 22, 2022
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- Active ingredients
- Purpose
- Use
- Warnings
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- Other information
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Inactive ingredients
aloe barbadensis leaf extract, carbomer, cetyl alcohol, cholecalciferol, glyceryl stearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, retinyl palmitate, sodium hydroxide, sodium sulfite, tocopheryl acetate, trisodium HEDTA, water
- Questions or comments
- Principal display panel - 28 g Carton Label
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INGREDIENTS AND APPEARANCE
ANTI-ITCH REGULAR STRENGTH
benzocaine and resorcinol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0621 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 RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL 2 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CETYL ALCOHOL (UNII: 936JST6JCN) CHOLECALCIFEROL (UNII: 1C6V77QF41) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ISOPROPYL STEARATE (UNII: 43253ZW1MZ) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM SULFITE (UNII: VTK01UQK3G) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRISODIUM HEDTA (UNII: K3E0U7O8KI) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0621-02 1 in 1 CARTON 01/09/2020 1 28 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 final part346 01/09/2020 Labeler - Walgreens (008965063) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(0363-0621)