FDA.reportPublic FDA data

Rugid Itch and Pain Relief

Manufacturer
R & R Lotion, Inc
Effective date
2021-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:57

Label at a glance#

ProductRugid Itch and Pain Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, Zinc Acetate
Label structure9 sections

Indications and uses

Temporary relieves pain and itching associated with: Insect Bites Minor Burns Minor Cuts Sunburn Minor Skin Irritations Scrapes Dries oozing and weeping of Poison Ivy, Poison Oak, and Poison Sumac Rashes due to Poison Ivy, Poison Oak, and Poison Sumac.

Dosage and administration

Do not use more than directed Hold stick stright down over infected area press tip of stick repeatedly on affect skin area until liquid flows, then dab sparingly adults and children 2 years of age and older: apply to affected area not more then 3 to 4 times daily children under 2 years of age: ask a doctor

Storage and handling

Protect from excessive heat (40ºC/104ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Diphenhydramine HCL 2%Topical Analgesic
Zinc Acetate 0.1%Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporary relieves pain and itching associated with: Insect Bites

  • Minor Burns
  • Minor Cuts
  • Sunburn
  • Minor Skin Irritations
  • Scrapes
  • Dries oozing and weeping of Poison Ivy, Poison Oak, and Poison Sumac
  • Rashes due to Poison Ivy, Poison Oak, and Poison Sumac.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only. Do not use on large areas of the body

  • with any other product containing diphenhydramine, even one taken by mouth.

OTC - ASK DOCTOR SECTION

Ask doctor before use on chicken pox

  • on measles

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask doctor if conditions worsen, or do not improve within 7 days

  • symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not use more than directed

  • Hold stick stright down over infected area
  • press tip of stick repeatedly on affect skin area until liquid flows, then dab sparingly
  • adults and children 2 years of age and older: apply to affected area not more then 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

Protect from excessive heat (40ºC/104ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Propylene Glycol, Xanthan Gum, DI Water, PVP K-30

Questions or Comments?

OTC - QUESTIONS SECTION

1-888-860-7424

PRINCIPAL DISPLAY PANEL - 20 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

R&R LOTION INC.

RUGID
OUTDOORS
EST. 84

ITCH
& PAIN
RELIEF
STICK

MINOR CUTS,
BITES & BURNS

USA

.76 FL. OZ. (20ML) e

Peel
Here

PRINCIPAL DISPLAY PANEL - 20 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 20 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1294589diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SolutionPSN2
1294589diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SolutionSCD2
1294589diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59555-010-182025-01-30C16284748780-12cef2736-75a7-d83d-e063-dadaa90ab31fRugid Itch and Pain Relief
59555-010-192025-01-30C16284748780-12cef2736-75a7-d83d-e063-dadaa90ab31fRugid Itch and Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-010-18Rugid Itch and Pain Relief1 mL in 1 PACKETLIQUID12
59555-010-19Rugid Itch and Pain Relief20 mL in 1 BOTTLE, WITH APPLICATORLIQUID202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59555-010RUGID ITCH AND PAIN RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) LIQUID [R & R LOTION, INC]2Legacy NDC, 2 package rows20210115_9cc4543c-12f9-46c8-864b-bc1f5705569a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59555-01059555-010-18, 59555-010-19

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
Zinc AcetateFM5526K07AACTIB
water059QF0KO0RIACT
Xanthan GumTTV12P4NEEIACT
Propylene Glycol6DC9Q167V3IACT
POVIDONE K30U725QWY32XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e969f3e2-6f53-4a2e-8ed7-ca63a6ccfcb49cc4543c-12f9-46c8-864b-bc1f5705569a2021-01-14WarningsExact identifier
spl id: e969f3e2-6f53-4a2e-8ed7-ca63a6ccfcb4
spl set id: 9cc4543c-12f9-46c8-864b-bc1f5705569a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.