09daa7a9-72f6-40c7-90f3-4c4f0852e99f

SPL v1
SPL
SPL Set ID 09daa7a9-72f6-40c7-90f3-4c4f0852e99f
Route
topical
Published
Effective Date 2011-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (700 mL)
Inactive Ingredients
water isopropyl alcohol glycerin eucalyptus oil methyl salicylate peppermint oil coconut oil

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2011-10-26

Purpose

Topical Analgesic

Description

OuWee Jones PAIN RELIEF SPRAY Pain Spray Drug Facts


Medication Information

Warnings

For external use only

Flammable. Keep away from flame.

Uses

Temporary relief of jellyfish stings.

Purpose

Topical Analgesic

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

Description

OuWee Jones PAIN RELIEF SPRAY Pain Spray Drug Facts

Principal Display Panel

NDC 76417-8200-1

Ou! Wee!

Jellyfish Sting Relief

#1 Recommended Jellyfish Pain Relief Spray

4 fl. oz. (118 ml)

Section 42229-5

OuWee Jones PAIN RELIEF SPRAY

Pain Spray

Drug Facts

Section 50565-1

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.

Active Ingredients

USP Menthol 7%


Structured Label Content

Warnings

For external use only

Flammable. Keep away from flame.

Uses

Temporary relief of jellyfish stings.

Purpose

Topical Analgesic

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 (PRINCIPAL DISPLAY PANEL)

NDC 76417-8200-1

Ou! Wee!

Jellyfish Sting Relief

#1 Recommended Jellyfish Pain Relief Spray

4 fl. oz. (118 ml)

Section 42229-5 (42229-5)

OuWee Jones PAIN RELIEF SPRAY

Pain Spray

Drug Facts

Section 50565-1 (50565-1)

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.

Active Ingredients

USP Menthol 7%


Advanced Ingredient Data


Raw Label Data

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