RELIEVEIT FOOTSPRAY TOPICAL ANALGESIC- menthol 8% liquid 
Cosmetic Specialty labs, 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.

----------

RelieveIt Footspray

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

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

refilllabel

RELIEVEIT FOOTSPRAY  TOPICAL ANALGESIC
menthol 8% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-956
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.2 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-956-0130 mL in 1 CARTON; Type 0: Not a Combination Product03/13/2020
2NDC:58133-956-0230 mL in 1 CARTON; Type 0: Not a Combination Product03/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/13/2020
Labeler - Cosmetic Specialty labs, Inc. (032973000)
Registrant - Cosmetic Specialty labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty labs, Inc.032973000manufacture(58133-956)

Revised: 3/2020
Document Id: a0c0b3e2-d72e-81bf-e053-2995a90ad9a0
Set id: a0c0cbac-6adf-d85d-e053-2995a90a5da5
Version: 1
Effective Time: 20200313
 
Cosmetic Specialty labs, Inc.