OVERTIME-X

Main information

  • Trade name:
  • OVERTIME-X- methyl salicylate, menthol, capsaicin lotion
  • Composition:
  • METHYL SALICYLATE 30 g in 100 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OVERTIME-X- methyl salicylate, menthol, capsaicin lotion
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Topical Analgesic For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 27495-019-01
  • Last update:
  • 03-06-2019

Summary of Product characteristics: dosage, interactions, side effects

OVERTIME-X- methyl salicylate, menthol, capsaicin lotion

Physician’s Science & Nature Inc.

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 INGREDIENTS

Methyl Salicylate 30%

Menthol 10%

Capsaicin 0.025%

Purpos e

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

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:

o

o

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:2749 5-0 19

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

30 g

in 10 0 mL

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED FORM

- UNII:L7T10 EIP3A)

MENTHOL, UNSPECIFIED

FORM

10 g

in 10 0 mL

CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM)

CAPSAICIN

.0 25 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

AMMO NIUM ACRYLO YLDIMETHYLTAURATE (UNII: KBC0 0 G9 5HI)

BENZO CAINE (UNII: U3RSY48 JW5)

BO RAGE SEED O IL (UNII: F8 XAG1755S)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

DIMETHYL SULFO XIDE (UNII: YOW8 V9 6 9 8 H)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

GINGER (UNII: C5529 G5JPQ)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SO DIUM STEARO YL GLUTAMATE (UNII: 6 5A9 F4P0 24)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:2749 5-0 19 -

30 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 1/0 1/20 17

Labeler -

Physician’s Science & Nature Inc. (012485755)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Westwo o d Labo rato ries Inc.

0 6 9 9 26 48 3

MANUFACTURE(2749 5-0 19 ) , LABEL(2749 5-0 19 )

Physician’s Science & Nature Inc.

Revised: 3/2019