FDA.reportPublic FDA data

Little Ouchies Little Remedies Pain Relief

Manufacturer
Medtech Products Inc.
Effective date
2009-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:54:30

Label at a glance#

ProductLittle Ouchies Little Remedies Pain Relief
Active ingredientBENZOCAINE, MENTHOL
Label structure8 sections

Indications and uses

For temporary relief of pain and itching associated with

Dosage and administration

Adults and children 2 years and older | Apply to affected area not more than 3 to 4 times daily  Children under 2 years of age | Consult doctor To use this product, hold can 6 to 12 inches away from affected area. Direct spray nozzle towards skin and press button to activate spray. To apply to face, first spray into palm of hand then touch hand to face.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Brand: Little Remedies

Product Line: Pain Relieving Spray

Strength/Flavor/Size: 2.75oz (78g)

Artwork #: LR24501

Active ingredients

DESCRIPTION SECTION

Benzocaine USP 20%

Menthol USP 0.5% 

Purpose

DESCRIPTION SECTION

Topical Analgesic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older | Apply to affected area not more than 3 to 4 times daily 

Children under 2 years of age | Consult doctor

To use this product, hold can 6 to 12 inches away from affected area. Direct spray nozzle towards skin and press button to activate spray. To apply to face, first spray into palm of hand then touch hand to face.

Other information

SPL UNCLASSIFIED SECTION

  • Caution: Avoid contact with leather, fabric and upholstery to prevent possible staining or discoloration.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetylated lanolin alcohol, aloe vera oil, butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben USP, PEG-8 laurate, polysorbate 85

Questions

For further information you may contact us at: 1-800-7-LITTLE Mon.-Fri. 8:00 a.m. to 8:00 p.m. EST, or visit us online at www.LittleRemedies.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEDICATED FOR KIDS 2+

LITTLE

OUCHIES TM 

By Little

Remedies

NEW!

PAIN

RELIEVING

SPRAY

Anesthetic

Ouch-proof application removes

Pain and itch from minor injuries

such as:

Cuts & Scrapes

Sunburn Insects Bites

Net Wt 2.75 oz (78 g)

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-100-022020-07-01C16284748780-19d75b9d0-2a4f-f424-e053-dadaa90a57ceLittle Ouchies Little Remedies Pain Relief
63029-100-022020-01-31C16284748780-19d75b9d0-2a4f-f424-e053-dadaa90a57ceLittle Ouchies Little Remedies Pain Relief

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW52
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
BENZOCAINEACTIVE MOIETYU3RSY48JW52
MENTHOLACTIVE MOIETYL7T10EIP3A2

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
63029-10063029-100-02

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
BENZOCAINEU3RSY48JW5ACTIB
MENTHOLL7T10EIP3AACTIB

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
1665233e-37b2-4398-a27a-1a8e3a69c4f8a4b73305-edf6-42cd-994a-0d7e3507a97d2020-07-06WarningsExact identifier
spl set id: a4b73305-edf6-42cd-994a-0d7e3507a97d

Reported adverse events (FAERS/openFDA)#

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