RELIEVEIT FOOTSPRAY TOPICAL ANALGESIC- menthol 8% liquid

RelieveIt Footspray by

Drug Labeling and Warnings

RelieveIt Footspray by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Menthol 8.0%

Purpose

External analgesic

Uses

For temporary relief of minor aches and pains of muscles, joints and feet.

Warnings

for external use only

When using this product: use only as directed avoid contact with eyes or mucous membrane do not apply to open wounds, damaged or very sensitive skin Do not use if you are allergic to any of this product's Active or Inactive ingredients

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Spray balls of feet. arches, heels, toes and legs on bare skin before starting your day or activity:

6 - 8 sprays each foot· Apply generously when wearing stockings; 8+ sprays each foot

Let dry completely Apply again as needed for extended relief

Children under 2: consult a doctor before use

Inactive ingredients

Arnica Montona, Cyclomethicone, Ethyl Alcohol. Ethoxydiglycol. Eucalyptus Oil. Horpogophytum. lsopropyl Palmitate, Lemon Oil, Lemongrass Oil, Pinus Resin, Propylene Glycol, Peppermint Oil, Teo Tree Oil, Wintergreen Oil

SPL UNCLASSIFIED SECTION

Manufactured for: SprainGo, LLC

3802 Spectrum Blvd, Suite 112E

Tampa, FL 33612

Made in the USA

Other Information

Do not use if the package seal is broken Store at 68-77°F (20 -25°)

Keep this package. It contains important information on directions for use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RELIEVEIT FOOTSPRAY  TOPICAL ANALGESIC
menthol 8% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-956
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.2 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)
CYCLOMETHICONE (UNII: NMQ347994Z)
BIS-ETHOXYDIGLYCOL CYCLOHEXANE 1,4-DICARBOXYLATE (UNII: R6MU0U9L45)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LEMON OIL (UNII: I9GRO824LL)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
PEPPERMINT OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
1-(3-AMINO-4-HYDROXYPHENYL)-2-((2-(4-METHOXYPHENYL)-1-METHYLETHYL)AMINO)ETHANOL (UNII: GJY78AX70Q)
PINUS RESINOSA WHOLE (UNII: AS8B4M6X9N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PROPYLENE GLYCOL 1-ALLYL ETHER (UNII: QRB8092KPK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-956-01	30 mL in 1 CARTON; Type 0: Not a Combination Product	03/13/2020
2	NDC: 58133-956-02	30 mL in 1 CARTON; Type 0: Not a Combination Product	03/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/13/2020

Labeler - Cosmetic Specialty labs, Inc. (032973000)

Registrant - Cosmetic Specialty labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty labs, Inc.		032973000	manufacture(58133-956)