OVERTIME- methyl salicylate, menthol and capsaicin lotion 
Physicians Science & Nature Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DB08-Overtime ®Pain Relief Lotion

Active Ingredients

Methyl Salicylate 30%

Capsaicin 0.0375%

Menthol USP 10%

Purpose

Topical Analgesic

USES:

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

KEEP OUT OF REACH OF CHILDREN AND PETS.

If swallowed get medical help or contact a Poison Control Center right away.

WARNINGS:

For external use only. Do not use in eyes, mouth or mucous membranes, or genitals. Do not allow treated skin to contact infants or pets. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products. May stain furniture, clothing or bedding.

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 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, in large amounts, especially over raw or blistered skin, if allergic to any ingredients, PABA, aspirin products, or sulfa. Store below 90°F/32°C.

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, Soy Lecithin, Methylparaben, Propylparaben, DMDM Hydantoin, Sodium Stearoyl Glutamate, Triethanolamine.

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

PHYSICIAN'S SCIENCE AND NATURE, INC.

OVERTIME ®

PAIN RELIEF LOTION

Deep Penetrating Action

With Natural Pain Relieving Ingredients

Dermatologically Tested

Hypoallergenic

NDC 27495-008-02

2 Oz. Label

2 oz Label

NDC 27495-008-04

4 Oz. Label

4 oz

OVERTIME 
methyl salicylate, menthol and capsaicin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27495-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE18 g  in 60 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 60 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0225 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BORAGE SEED OIL (UNII: F8XAG1755S)  
GINGER (UNII: C5529G5JPQ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
TROLAMINE (UNII: 9O3K93S3TK)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27495-008-0250 in 1 CARTON01/01/2007
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:27495-008-0450 in 1 CARTON01/01/2007
2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2007
Labeler - Physicians Science & Nature Inc. (012485755)
Registrant - Westwood Laboratories, LLC (832280635)

Revised: 11/2023
Document Id: 099849f6-7f19-afc2-e063-6294a90a8d5c
Set id: 25fec070-8587-42d1-ba6f-1a9c150acc98
Version: 5
Effective Time: 20231107
 
Physicians Science & Nature Inc.