OVERTIME-X- methyl salicylate, menthol, capsaicin lotion

OVERTIME-X by

Drug Labeling and Warnings

OVERTIME-X by is a Otc medication manufactured, distributed, or labeled by Physician’s Science & Nature Inc., Westwood Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

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. Store below 90oF/32oC.

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, 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

INGREDIENTS AND APPEARANCE

OVERTIME-X 
methyl salicylate, menthol, capsaicin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27495-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 g  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.025 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
BENZOCAINE (UNII: U3RSY48JW5)
BORAGE SEED OIL (UNII: F8XAG1755S)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GINGER (UNII: C5529G5JPQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27495-019-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2017

Labeler - Physician’s Science & Nature Inc. (012485755)

Establishment
Name	Address	ID/FEI	Business Operations
Westwood Laboratories Inc.		069926483	MANUFACTURE(27495-019) , LABEL(27495-019)