Other
OuWee Jones PAIN RELIEF SPRAY
Pain Spray
Drug Facts
Analgesic
FDA Label NDC 76417-8200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ouwee Jones, Llc for the product Analgesic (NDC 76417-8200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
USP Menthol 7%
Purpose
Topical Analgesic
Uses
Temporary relief of jellyfish stings.
Warnings
For external use only
Flammable. Keep away from flame.
Otc - Keep Out Of Reach Of Children
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)
Principal Display Panel (Ouw01 0000 01)
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