Label: IVY WASH- pramoxine hydrochloride lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 0395-0119-96 - Packager: Humco Holding Group, Inc.
- 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 December 14, 2017
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- Official Label (Printer Friendly)
- active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
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Directions
Adult and children 2 years of age and older. Wet affected areas. Apply the product to affected skin and surrounding area. work foam into a lather and rub for up to 3 minutes, if needed. Do not leave on skin for longer than 3 minutes. throughly rinse product from all areas. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age. Consult a doictor.
- Other Information
- Keep out of reach of children
- Inactive Ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
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Principal display panel
Dual Action with Jojoba. NDC 0395-0119-96. IVY WASH. POISON IVY CLEANER. FAST ACTING ITCH RELIEF. SAFE FOR USE IN CHILDREN. SAFE FOR USE DURING PREGNACY. UNIQUE 2-IN-1 FORMULA. #1) Starts to work in seconds to remove Poison Ivy Oil (Urishiol), and helps minimize the damaging effects of Poison Ivy contamination. #2) Stops itching FAST. 6OZ (177 mL).
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INGREDIENTS AND APPEARANCE
IVY WASH
pramoxine hydrochloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-0119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) GLYCOL DISTEARATE (UNII: 13W7MDN21W) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERIN (UNII: PDC6A3C0OX) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) NONOXYNOL-9 (UNII: 48Q180SH9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-0119-96 117 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2008 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 label(0395-0119) , manufacture(0395-0119) , pack(0395-0119) , analysis(0395-0119)