Pain Relieving Analgesic

Dosage form: gel
Ingredients: MENTHOL 4.54g in 1g
Labeler: Singhfam Corporation
NDC Code: 52920-123

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.

Analgesic Gel

Active Ingredients

Menthol 2%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and muscles pain: simple back aches, sprains and strains common to sports activities, joint pains associated with arthritis.

Directions

Clean skin of all other lotions, creams, ointments, liniments: Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times within a 24 hour period. No protective cover needed. Do not apply to children under 2 years of age.

Warnings

Use only as directed.

Keep out of reach of children.

For external use only. If swallowed contact a physician or poison control center immediately. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free of any creams ointments, sprays or liniments. Do not cover with bandage.

Do not use

with heating pads or heating devices.

Discontinue use and consult a physician if skin irritation develops, condition recurs, worsens or symptoms persist for more that 7 days. Consult your doctor before use if you are pregnant or nursing. Do not use, pour, spill or store near heat or open flame. Store in a cool, dry place. Keep lid tightly closed.

Inactive Ingredients

Water, Isopropyl Alcohol, Nonoxynol-10, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone & Mathylisothiazolinone, FD&C Blue #1.

PRINCIPAL DISPLAY PANEL
elizabeth style
Therapeutic, Greaseless
Fast, temporary relief from minor aches and pains
Blue Ice
Net Wt. 8 Oz (227 g)
PAIN RELIEVING ANALGESIC GEL

PAIN RELIEVING ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-123
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4.54 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
CAMPHOR (SYNTHETIC) 
CARBOMER 934 
SODIUM HYDROXIDE 
METHYLISOTHIAZOLINONE 
FD&C BLUE NO. 1 
NONOXYNOL-10 
Packaging
#Item CodePackage Description
1NDC:52920-123-03227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/21/2009
Labeler - Singhfam Corporation (019499958)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd.916837425MANUFACTURE(52920-123)

Revised: 01/2012
 
Singhfam Corporation

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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