OVERTIME- methyl salicylate, menthol and capsaicin lotion

Overtime by

Drug Labeling and Warnings

Overtime by is a Otc medication manufactured, distributed, or labeled by Physicians Science & Nature Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Methyl Salicylate 30%

Capsaicin 0.0375%

Menthol USP 10%

Purpose

Topical Analgesic

USES:

For temporary relief of minor aches and pain of muscles and joints associated with arthritis, simple backache, sprains, and strains. Does not cure any disease.

WARNINGS:

• For external use only
• Avoid contact with eyes, mouth, mucous membranes, or genitals
• Do not tightly bandage
• Ask a physician before use if pregnant, nursing or taking anticoagulant medication.

Keep away from children

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 no more than 4 times daily. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. If swallowed, call Poison Control. If placed into eyes, rinse with cold water and call a physician. Store below 90°F/32°C.

Do Not Use:

• On wounds, irritated or damaged skin
• In excessive amounts
• With a heating pad
• With other topical pain products
• On children under 12 years old
• If allergic to ingredients listed or aspirin products.

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, soya lecithin, methylparaben, propylparaben, DMDM hydantoin, sodium stearoyl glutamate, triethanolamine.

SPL UNCLASSIFIED SECTION

Manufactured for Physician's Science and Nature Inc.
220 Newport Center Drive 11-634, Newport Beach, CA 92660
For information, or to place a new order visit:
www.overtimepainrelief.com or call (888) 441-6680

Made in the USA
Patent Pending

Principal Display Panel - 2 oz

PHYSICIAN'S SCIENCE AND NATURE, INC.

OVERTIME®
PAIN RELIEF LOTION

Deep Penetrating Action
CLINICALLY TESTED

2 oz (60 ml)
NDC: 27495-008-02

2 oz Label

INGREDIENTS AND APPEARANCE

OVERTIME 
methyl salicylate, menthol and capsaicin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27495-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	18 g  in 60 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 60 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0225 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27495-008-02	50 in 1 CARTON	01/01/2007
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 27495-008-04	50 in 1 CARTON	01/01/2007
2		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2007

Labeler - Physicians Science & Nature Inc. (012485755)