Home NDC 0395-0119 Ivy Wash
Product NDC 0395-0119
11-digit product format 003950119
Labeler code 0395
Product ID 0395-0119_604fda97-cb16-13eb-e053-2991aa0aa452
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine Hydrochloride
Dosage form LOTION
Route TOPICAL
Labeler Humco Holding Group, Inc.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2008-01-01
Marketing end 0000-00-00
Substance PRAMOXINE HYDROCHLORIDE
Active strength 10 1/mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 0395-0119 I Inactivated by FDA 2026-07-31 excluded package package 0395-0119 0395-0119-96 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rugby Muscle Rub Cream MUSCLE RUB CREAM Preferred Pharmaceuticals Inc. ea209a4e-acad-413b-8fb9-27e98130bcd6 2026-07-28 Warnings Exact identifier hydrocortisone HYDROCORTISONE Preferred Pharmaceuticals Inc. 12cd35e3-e707-4551-b778-bf615c1a8d32 2026-05-11 Warnings Exact identifier Arthritis Pain Relieving Cream MENTHOL, METHYL SALICYLATE International Nature Nutraceuticals, Inc. 2c9d070c-bf90-4482-8a6e-c7491cdd34c5 2025-12-27 Warnings Exact identifier New Terocin METHYL SALICYLATE, CAPSAICIN, AND MENTHOL Preferred Pharmaceuticals Inc. 186445d4-ef73-4d34-849d-4661a3eaa43a 2025-09-30 Warnings Exact identifier Terocin LIDOCAINE, MENTHOL Preferred Pharmaceuticals, Inc. 23843354-e242-4a8a-8818-897592d4d9a0 2025-09-30 Warnings Exact identifier Discount Drug Mart Regular Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Discount Drug Mart 8748c31d-8258-0357-e053-2a95a90a9c22 2019-04-24 Warnings Exact identifier Best Choice Itch Relief DIPHENHYDRAMINE HCL, ZINC ACETATE Valu Merchandisers 873591ef-16cb-ab90-e053-2991aa0a865d 2019-04-23 Warnings Exact identifier Fire Out BENZOCAINE AND MENTHOL Randob Ltd. 77ab634e-13d4-4f5f-87c8-73976e65a842 2019-04-12 Warnings Exact identifier Discount Drug Mart Anti-itch HYDROCORTISONE DISCOUNT DRUG MART, INC. 853eee29-6f57-59d4-e053-2991aa0aa611 2019-03-29 Warnings Exact identifier MEDICATED LIP BALM MENTHOL AND EUCALYPTUS Burt's Bees, Inc. 30da3cc5-6140-2dee-e054-00144ff8d46c 2018-12-21 Warnings Exact identifier Instaflex Pain Relief Cream MENTHOL Adaptive Health, LLC 911f5021-a851-444e-8c2a-2be4fa94e828 2018-12-21 Warnings Exact identifier Fast Freeze CAMPHOR (NATURAL), MENTHOL Natural Essentials Inc. 60c94da8-6c00-4544-a9a6-a3e87ebabd68 2018-10-18 Warnings Exact identifier Analgesic MENTHOL Safetec of America, Inc. a90266d4-1e71-4805-aeca-6f8ed45135bb 2018-10-01 Warnings Exact identifier COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF MENTHOL NATURAL ESSENTIALS, INC. 9fcc79e6-8176-4ebc-8602-0649b02fab86 2018-09-27 Warnings Exact identifier Capsaicin Pain Relief CAPSAICIN Kareway Product, Inc. dce9db37-cd07-44d8-8881-f63a2191964f 2018-06-07 Warnings Exact identifier Pure-Aid CAMPHOR, MENTHOL, METHYL SALICYLATE Kareway Product, Inc. 6def9da7-e118-fd5c-e053-2991aa0a65d2 2018-06-05 Warnings Exact identifier Soundbody LIDOCAINE, MENTHOL Kareway Product, Inc. 6c83ec36-3e3d-07a9-e053-2a91aa0ac54c 2018-05-18 Warnings Exact identifier Avedana Cool Hot Ice MENTHOL Unipack, Inc. 619c8e3f-0cad-4eb1-8dbb-632f3db74ba3 2018-05-01 Warnings Exact identifier SunBurnt PLUS Pain Relief LIDOCAINE HYDROCHLORIDE Welmedix LLC dba Welmedix Consumer Healthcare 6363c695-f801-407d-a4e1-b0d9cfa0a273 2018-03-13 Warnings Exact identifier Pure-Aid LIDOCAINE, MENTHOL Kareway Product, Inc. 6679cada-f083-26e8-e053-2a91aa0adcc5 2018-03-02 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only Avoid contact with eyes and mucous membranes • If conditions worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. • Do not apply to wounds or damaged skin. • Do not apply bandage tightly. • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin. • Discontinue use if excessive irritation of skin develops. • If pregnant or breast feeding, ask a health professional before use. • A temporary burning sensation may occur upon application, but generally disappears in a few days.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0395-0119-96 Ivy Wash 117 mL in 1 BOTTLE LOTION 117 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 AMMONIUM LAURYL SULFATE INACTIVE INGREDIENT Q7AO2R1M0B IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 GLYCOL DISTEARATE INACTIVE INGREDIENT 13W7MDN21W IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 HYDROLYZED JOJOBA ESTERS (ACID FORM) INACTIVE INGREDIENT UDR641JW8W IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 NONOXYNOL-9 INACTIVE INGREDIENT 48Q180SH9T IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-0119 IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 2 Legacy NDC, 1 package rows 20171214_3323f8fe-5219-4e3d-9622-3680d60555a5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0395-0119-96 00395011996 117 mL in 1 BOTTLE (0395-0119-96) 117 ml 2017-12-14 0000-00-00 No No Current