Desensitizing cream

Manufacturer
I Shay Cosmetics Inc
Effective date
2022-10-18
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 23:51:04

Label at a glance#

ProductWakaya RuRu Topical Analgesic
Active ingredientMENTHOL
Label structure9 sections

Dosage and administration

Adults ands children 2 years of age and older: Apply to affected area not more than 3 to 4 times per day. Children under 2 years of age: Consult a physician

Storage and handling

Store in a cool, dry place.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%..................... Topical Analgesic

OTC - PURPOSE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

If pregnant or breast-feeding, ask a health professional before use.

If swallowed get medical help or contact poisoncontrol center right away.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water

Cetylated Fatty Acids (Myristoleate, Myristate, Laurate, Palmitate, and Oleate)

Stearic Acid

Glyceryl Stearate

Glycerin

Benzyl Alcohol

Mentha Piperita (Peppermint Oil)

Lecithin

Phenoxyethanol

Sodium Hydroxide

Carbomer

Tocopheryl Acetate

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.

Do not bandage tightly

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults ands children 2 years of age and older: Apply to affected area not more than 3 to 4 times per day. Children under 2 years of age: Consult a physician

Other Information

STORAGE AND HANDLING SECTION

Store in a cool, dry place.

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416982menthol 1.25 % Topical CreamPSN10
416982menthol 12.5 MG/ML Topical CreamSCD10
416982menthol 1.25 % Topical CreamSY10

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65112-265-01Wakaya RuRu Topical Analgesic71 g in 1 BOTTLE, PUMPCREAM7110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65112-265WAKAYA RURU TOPICAL ANALGESIC (EXTERNAL ANALGESIC) CREAM [I SHAY COSMETICS INC]10Legacy NDC, 1 package rows20221019_3e018d33-8f68-48dc-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65112-26565112-265-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT

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
eb562c79-2ccc-3ddc-e053-2a95a90a7bb83e018d33-8f68-48dc-e054-00144ff8d46c2022-10-18WarningsExact identifier
spl id: eb562c79-2ccc-3ddc-e053-2a95a90a7bb8
spl set id: 3e018d33-8f68-48dc-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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