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Analgesic

Ouwee Jones, LLC
Safetec of America, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OuWee Jones PAIN RELIEF SPRAY

Pain Spray

Drug Facts

Active Ingredients

USP Menthol 7%

Purpose

Topical Analgesic

Uses

Temporary relief of jellyfish stings.

Warnings

For external use only

Flammable. Keep away from flame.

Keep out of reach of children. If swallowed get medical help or contact a poison center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Directions

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information

Store at room temperature.

Inactive Ingredients

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil.

Questions or Comments
855-37-OUWEE or
www.ouweejones.com

Distributed By:
OuWee Jones Co.
PO Box 118, Mobile, AL 36601
www.ouweejones.com

PRINCIPAL DISPLAY PANEL

NDC 76417-8200-1

Ou! Wee!

Jellyfish Sting Relief

#1 Recommended Jellyfish Pain Relief Spray

4 fl. oz. (118 ml)

Analgesic

menthol SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76417-8200
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 700 mL

Inactive Ingredients

Ingredient Name Strength
water
ISOPROPYL ALCOHOL
GLYCERIN
EUCALYPTUS OIL
methyl salicylate
PEPPERMINT OIL
COCONUT OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76417-8200-1 0.118 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2011-10-26


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