Label: REESES PINWORM ITCH RELIEF- pramoxine hydrochloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 10956-799-20 - Packager: Reese Pharmaceutical Co
- 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 October 2, 2017
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- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of the reach of children.
- Direction
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
REESES PINWORM ITCH RELIEF
pramoxine hydrochloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10956-799 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10956-799-20 89 g in 1 PACKAGE; Type 0: Not a Combination Product 10/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/21/2013 Labeler - Reese Pharmaceutical Co (004172052) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Guy & O'Neill, Inc. 138513069 manufacture(10956-799) , label(10956-799)