RESTORE FAST ACTING PAIN- menthol, unspecified form cream

RESTORE by

Drug Labeling and Warnings

RESTORE by is a Otc medication manufactured, distributed, or labeled by Hope Science Inc., Lifetech Resources LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Menthol (1.25%)

Purpose

Topical Analgesic

Indications

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

• For external use only.

• Avoid contact with eyes.
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.

Keep out of reach of children.

• If swallowed, get medical help or contact a poison control center right away.

Directions

Adults and children 2 yrs. of age and older, apply to affected area not more than 3 to 4 times a day. Children under 2 yrs. of age, consult a physician.

Other Information

Store in a cool, dry place.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylyl Glycol, Citric Acid, Esterified Fatty Acids (EFAC Proprieatry Blend), Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Lecithin, Mentha Piperita (Peppermint) Oil, PEG-100 Stearate, Phenoxyethanol, Sodium Hydroxide, Tocopheryl Acetate, Water.

Questions?

1-866-628-8725

www.HopeScience.com

SPL UNCLASSIFIED SECTION

Distributed by Hope Science Inc.

PRINCIPAL DISPLAY PANEL - 4 fl oz Jar Label

Real Hope Thanks to Great Science

Hope™
Science

RESTORE™
Defeat Pain, Don't Mask It

FAST ACTING PAIN CREAM
4 fl oz

INGREDIENTS AND APPEARANCE

RESTORE  FAST ACTING PAIN
menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71970-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	12.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETYL TALLOWATE (UNII: MVY7P518D2)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PEPPERMINT OIL (UNII: AV092KU4JH)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71970-301-06	118 mL in 1 JAR; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2018

Labeler - Hope Science Inc. (049917199)

Registrant - Lifetech Resources LLC (622559110)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources LLC		622559110	MANUFACTURE(71970-301)