Overtime Lotion
FDA Label NDC 27495-008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Science & Nature Inc. for the product Overtime (NDC 27495-008). 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 active ingredients, purpose, uses:, warnings:, directions:, do not use:, stop use and ask a physician:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Methyl Salicylate 30%

Capsaicin 0.0375%

Menthol USP 10%

Purpose

Topical Analgesic

Uses:

For temporary relief of minor aches and pain of muscles and joints associated with arthritis, simple backache, sprains, and strains. Does not cure any disease.

Warnings:

  • For external use only
  • Avoid contact with eyes, mouth, mucous membranes, or genitals
  • Keep away from children
  • Do not tightly bandage
  • Ask a physician before use if pregnant, nursing or taking anticoagulant medication.

Directions:

Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas no more than 4 times daily. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. If swallowed, call Poison Control. If placed into eyes, rinse with cold water and call a physician. Store below 90°F/32°C.

Do Not Use:

  • On wounds, irritated or damaged skin
  • In excessive amounts
  • With a heating pad
  • With other topical pain products
  • On children under 12 years old
  • If allergic to ingredients listed or aspirin products.

Stop Use And Ask A Physician:

  • For severe undiagnosed pain
  • If pain worsens or persist for more than 7 days
  • If pain clears up and then recurs in a few days
  • If itching or rash occurs.

Inactive Ingredients:

water, glyceryl stearate, PEG 100 stearate, stearic acid, propylene glycol, cetyl alcohol, dimethyl isosorbide, poloxamer 407, aloe barbadensis gel, borage oil, copolymer, zingiber officinale root extract, boswellia serrata extract, soya lecithin, methylparaben, propylparaben, DMDM hydantoin, sodium stearoyl glutamate, triethanolamine.

Other

Manufactured for Physician's Science and Nature, Inc.

220 Newport Center Drive 11-634, Newport Beach, CA 92660

For information, or to place a new order visit:
www.overtimepainrelief.com or call (888) 441-6680

Made in the USA

Patent Pending

Principal Display Panel - 2 Oz

PHYSICIAN'S SCIENCE AND NATURE, INC.

OVERTIME®

PAIN RELIEF LOTION

Deep Penetrating Action

CLINICALLY TESTED

2 oz (60 ml)

NDC 27495-008-02

Principal Display Panel (2 oz Label)

Principal Display Panel (2 oz Label)

2 oz Label

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