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

Uses

USES:

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

Warning

Warning

For external Use only.

Directions

ADirections:

Adults and children 2 years of age and older:

Apply to painful muscles and joints. Genthly massage thtoughly into affected areas.

Repeat as necessary but not more than 4 times daily.

Ask doctor before use if you:

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 nopt apply to irrated skin or ifexcessive irration develops.

Do not bandage.

Wash hands after use with cool water.

Do not use with heating pad or device.

Stop Use and Ask a Doctor if:

Stop use and Ask doctor If: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

Keep out of reach of children:

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

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.

Other information

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

Inactive Ingredients

Inactive Ingredients:

Aqueou(Deionized 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, FDC Yellow#5, Methylparaben, Triethanolamine.

If pregnant or breast feeding:

If pregrant or breast feeding. Ask a health professional before use.

Principle Dislay Panel

30056-004-3230056-004-28

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:30056-004-283780 g in 1 JUG; Type 0: Not a Combination Product07/11/2016
2NDC:30056-004-32877 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: fb48a6a3-8cd4-d3a5-e053-6294a90adac5
Set id: 70eda21e-e566-42f4-9a49-b0d3ad000652
Version: 26
Effective Time: 20230509
 
Eco-Logics, Inc.