LITTLE OUCHIES LITTLE REMEDIES PAIN RELIEF- benzocaine and menthol aerosol, spray

Little Ouchies Little Remedies Pain Relief by

Drug Labeling and Warnings

Little Ouchies Little Remedies Pain Relief by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Brand: Little Remedies

Product Line: Pain Relieving Spray

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

Artwork #: LR24501

Active ingredients

Benzocaine USP 20%

Menthol USP 0.5% 

Purpose

Topical Analgesic

Topical Analgesic

Uses

For temporary relief of pain and itching associated with

Directions

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

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

Inactive ingredients

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

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)

INGREDIENTS AND APPEARANCE

LITTLE OUCHIES LITTLE REMEDIES PAIN RELIEF 
benzocaine and menthol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-100-02	78 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	12/31/2009

Labeler - Medtech Products Inc. (122715688)