THE RELIEF COMPANY- menthol gel 
Symedic LLC

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.

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Drug Facts

Active Ingredient

Menthol 2%

Purpose

Topical analgesic

Use

Temporary relief from minor aches and pains of sore muscles & joints associated with

Warnings

For external use only.

When using this product

Stop use and ask a doctor if conditions worsen, or if symptoms persist for more than 7 days, or clear up and reoccur.

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

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and older: Spray onto affected areas no more than 4 times daily; massage not necessary. Children under 12 years of age: consult a physician.

Other Information

Store in a cool dry place with lid closed tightly.

Inactive Ingredients

dimethyl sulfone, dimethyl sulfoxide, eucalyptus oil*, hydrogen peroxide, peppermint oil*, spike lavender oil*, water.

Relleve Naturals - Menthol Spray [​7140288801]

New

7140288801

Relleve Naturals

Deep Penetrating Pain Relief

Topical Spray

1 fl oz / 30 ml

Relleve Naturals Labels

THE RELIEF COMPANY 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71402-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA (UNII: O80TY208ZW)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71402-101-0189 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/03/2019
Labeler - Symedic LLC (060844542)

Revised: 9/2019
Document Id: 91ab319c-db6c-7749-e053-2a95a90ae6fd
Set id: 8e60a0ef-8947-7fa7-e053-2995a90a065c
Version: 5
Effective Time: 20190903
 
Symedic LLC