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Analgesic

Safetec of America, Inc.

Safetec of America, Inc. PAIN SPRAY


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Pain Spray

Drug Facts

Active Ingredients

USP Menthol 7%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints.

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.

Manufactured by
SAFETEC OF AMERICA, Inc. Buffalo, NY 14215
800-456-7077 www.safetec.com

PRINCIPAL DISPLAY PANEL

NDC 61010-8200-1

Safetec

First Aid

Pain Spray

For Temporary

Pain Relief of

Minor Aches

And Pains

4 fl. oz. (118 ml)

Analgesic

menthol SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61010-8200
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:61010-8200-1 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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