Elgin Pain Relief

Dosage form: gel
Ingredients: Menthol 35mg in 1g
Labeler: Eco-Logics, Inc.
NDC Code: 30056-004

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.

Drug Facts

Active Ingredients                         Purpose

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


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.


Warnings

Warnings:

For external use only.

Directions

Directions

Adults and children 2 years of age and older:

  • Apply to painful muscles and joint. Gently 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 mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation 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 A Doctor 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 or children.

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

Directions

Directions

Adults and children 2 years of age and older:

  • Apply to painful muscles and joint. Gently massage thoroughly 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:



Aqueous (Deionized 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, FDC Yellow #10,
Methylparaben, Triethanolamine.


ELGIN PAIN RELIEF 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30056-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol35 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Aloe Vera Leaf 
Isopropyl Alcohol 
Ilex Paraguariensis Leaf 
Camphor (Natural) 
Alpha-Tocopherol 
Carbomer Homopolymer Type C 
FD&C Blue No. 1 
D&C Yellow No. 10 
Methylparaben 
Trolamine 
Packaging
#Item CodePackage Description
1NDC:30056-004-32877 g in 1 BOTTLE, PUMP
2NDC:30056-004-283780 g in 1 JUG
3NDC:30056-004-055 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/15/2009
Labeler - Eco-Logics, Inc. (047667022)

Revised: 04/2012
 
Eco-Logics, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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