overtime ®

overtime ®
SPL v10
SPL
SPL Set ID 25fec070-8587-42d1-ba6f-1a9c150acc98
Route
topical
Published
Effective Date 2023-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (18 g) menthol (6 g) capsaicin (0.0225 g)
Inactive Ingredients
water glyceryl monostearate peg-100 stearate stearic acid propylene glycol cetyl alcohol dimethyl isosorbide poloxamer 407 aloe vera leaf borage seed oil ginger indian frankincense lecithin, soybean methylparaben propylparaben dmdm hydantoin trolamine sodium stearoyl glutamate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2007-01-01

Purpose

Topical Analgesic

Description

Methyl Salicylate 30% Capsaicin 0.0375% Menthol USP 10%


Medication Information

Purpose

Topical Analgesic

Description

Methyl Salicylate 30% Capsaicin 0.0375% Menthol USP 10%

Uses:

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

Section 42229-5

Manufactured for Physician's Science and Nature Inc.

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

Manufactured in the USA

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.

Active Ingredients

Methyl Salicylate 30%

Capsaicin 0.0375%

Menthol USP 10%

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.

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.

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

NDC 27495-008-04

4 Oz. Label

Keep Out of Reach of Children and Pets.

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


Structured Label Content

Purpose

Topical Analgesic

Uses: (USES:)

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

Section 42229-5 (42229-5)

Manufactured for Physician's Science and Nature Inc.

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

Manufactured in the USA

Warnings: (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: (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: (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.

Active Ingredients

Methyl Salicylate 30%

Capsaicin 0.0375%

Menthol USP 10%

Inactive Ingredients: (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.

Stop Use and Ask A Physician: (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.

Physician's Science and Nature, Inc. (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

NDC 27495-008-04

4 Oz. Label

Keep Out of Reach of Children and Pets. (KEEP OUT OF REACH OF CHILDREN AND PETS.)

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


Advanced Ingredient Data


Raw Label Data

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