ELGIN PAIN RELIEF- menthol gel 
Eco-Logics, 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.

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OTC-ACTIVE INGREDIENT SECTION

Active Ingedients Purpose

Menthol USP 3.5%................... Topical Analgesic

Menthol USP 3.5% Topical Analgesic

Uses

Uses:

Temporary relief from minor pains of sore muscles and jpintsassociated with arthritis, backache, strains, and sprains..

Warning

WARNING:

For external use only.

Directions

Directions

Adults and children 2 years of age and older:

Apply to painful muscles and joint. Genthly massage thoroughly into affected area.

Repeat as necessary but not more than 4 times daily.

Ask a doctor before use if you have:

Ask a doctor before use if you have Sensitive skin.

When Using this Product:

When Using this product:

Avoid contact with the eyes or muscous membranes

Do not apply to wounds or damaged skin

Do not use with other ointmens, creams, sprays, or linaments.

Do not apply to irritated skin or if excessive irration develops

Do not bandage

Wash hands after use with cool water

Do not use with heating pad or device.

Stop Use and Ask Doctor If:

Stop Use and Ask Doctor If: Condition worsens, or if symtoms persist for more than 7 days, or clear up and reoccur.

If pregnant or breast feeding:

If Pregnant or breast feeding: Ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children. If accidentally ingested, get medicalhelp or contact a Poisan Control Center immediately.

immedaAqueous (Deionized filtered water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *IlexParaguariensis leaf extract, Cinnamomum Camphora (camphor),Tocopheryl Avetate (Vitamin E Acetate), Carbomer, FD&C Blue #1, FD&C Yellow #5, Methylparaben, Triethanolamine.

Directions:

Directions:

Adults and children 2 years of age and older

Apply to painful muscles and joints. Genthly massage thoroughly into affected area.

Repeat as necessary but not more than 4 times daily.

Other infirmation:

Other Information: Store in a cool dry place with lid closed tightly.

Inactive Ingredients

Inactive Ingredients:

Aqueous (Deionozed filtered water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *Ilex Paraguariensis Leaf Extract, Cinnamomum Camphora (camphor),Tocopheryl Acetate (Vitamin E Acetate), Carbomer, FDC Blue #1, FDCYellow #5, Methylparaben, Triethanolamine.

30056-004-0430056-004-03

ELGIN PAIN RELIEF 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30056-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30056-004-0385 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/11/2016
2NDC:30056-004-04113.4 g in 1 TUBE; Type 0: Not a Combination Product07/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/11/2016
Labeler - Eco-Logics, Inc. (047667022)
Registrant - Elginex Corporation (005142799)
Establishment
NameAddressID/FEIBusiness Operations
Natural Essentials,Inc.947484713manufacture(30056-004)

Revised: 5/2023
Document Id: fb0bcdb1-a99e-6a21-e053-6394a90aa611
Set id: 375bfe83-c895-3ea7-e054-00144ff88e88
Version: 5
Effective Time: 20230506
 
Eco-Logics, Inc.