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OVERTIME-X

Medically reviewed on January 25, 2017

Dosage form: lotion
Ingredients: METHYL SALICYLATE 30g in 100mL, MENTHOL, UNSPECIFIED FORM 10g in 100mL, CAPSAICIN .025g in 100mL
Labeler: Physician’s Science & Nature Inc.
NDC Code: 27495-019

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Methyl Salicylate 30%

Menthol 10%

Capsaicin 0.025%

Purpose

Topical Analgesic

Uses:

For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Warnings:

For external use only. Do not use in eyes, mouth, on mucous membranes, or genitals. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products. May stain furniture.

Keep Out of Reach of Children and Pets

Keep away from children and pets. Do not allow treated skin to contact infants or pets.

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. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If swallowed, call poison control. If placed into eyes, rinse with cold water and call a doctor.

Do Not Use:

On cuts or infected skin, on children less than 12 years old, on pets, in large amounts, especially over raw or blistered skin, if allergic to any ingredients, PABA, aspirin products, or sulfa.

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.

Storage:

Store below 90oF/32oC.

Inactive Ingredients:

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

Manufactured for:

Manufactured for Physician’s Science and Nature Inc.
220 Newport Center Drive 11-634, Newport Beach, CA 92660

Made in the USA
Patent Pending

Package/Label Principal Display Panel

PHYSICIAN’S SCIENCE AND NATURE, INC.

OVERTIME-X®

PAIN RELIEF LOTION
Deep Penetrating Action
Dermatologically Tested
Hypoallergenic

30 ml (1 fl oz)
NDC 27495-019-01

BOTTLE LABEL

OVERTIME-X 
methyl salicylate, menthol, capsaicin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27495-019
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE30 g  in 100 mL
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM10 g  in 100 mL
CAPSAICIN (CAPSAICIN) CAPSAICIN.025 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
AMMONIUM ACRYLOYLDIMETHYLTAURATE 
BENZOCAINE 
BORAGE OIL 
CETYL ALCOHOL 
DIMETHYL SULFOXIDE 
DMDM HYDANTOIN 
GINGER 
GLYCERYL MONOSTEARATE 
LECITHIN, SOYBEAN 
METHYLPARABEN 
PEG-100 STEARATE 
POLOXAMER 407 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM STEAROYL GLUTAMATE 
STEARIC ACID 
WATER 
Packaging
#Item CodePackage Description
1NDC:27495-019-0130 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2017
Labeler - Physician’s Science & Nature Inc. (012485755)
Establishment
NameAddressID/FEIOperations
Westwood Laboratories Inc.069926483MANUFACTURE(27495-019), LABEL(27495-019)

 
Physician’s Science & Nature Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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