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

Purpose

Menthol USP 3.5% Topical Analgesic

Warnings

Warnings:

For external use only.

Directions:

Directions:

Adults and children 2 years of age and older:

Apply to painful muscles and joints. Genthly massage throughly 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 mucous membranes.

Do not apply to wounds or damaged skin.

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

Do not apply to irrated skin or excessive irration develops.

Do not bandage.

Wash hands after use with cool water.

Dop not use with heating pad or device.

Stop Use and ask a doctor if::

Stop use and ask a Dictor if: Condition worsens, or if symptoms 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 accidenthly ingested get medical help or contact a Poison Control Center.

Inactive Ingredients:

Aqueous (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.

Dosage and Administration

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 information:

Other information: Stiore in a cool dry place with lid closed tightly.

USES:

USES:
Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.

Principle Display Panel

30056-004-16

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)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30056-004-16454 g in 1 BOTTLE, PUMP; 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: fb493a10-73b9-5073-e053-6294a90a7f7f
Set id: 378d1109-6511-1f63-e054-00144ff88e88
Version: 8
Effective Time: 20230509
 
Eco-Logics, Inc.