Pain Relieving Gel

Pain Relieving Gel

Drug Labeling and Warnings

Drug Details

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PAIN RELIEVING- menthol gel 
Cardinal Health

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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Pain Relieving Gel

Drug Facts

Active Ingredients

Active Ingredients                   
Menthol 3.5%

Purpose

Cooling Pain Relief

Uses

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

Warnings:

For external use only

Ask a doctor before use if you have:

sensitive skin, are pregnant or breast feeding

When Using This Product:

Avoid contact with eyes or mucous membranes

Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops

Do not bandage or use with heating pad or device. ointments, creams, sprays. liniments

Wash hands after with cool water

Stop Use And Ask A Doctor If:

Condition worsens. symptoms persist more than 7 days, or clear up and recur

Keep out of reach of children:

If ingested, get medical help. Contact Poison Control Center immediately.

Directions:

Adults / Children 2 years and older: Massage onto affected area up to 4 times daily.  Children under 2 years of age: Consult physician

Other Information:

Store in cool dry place, lid closed tightly. keep away from excessive heat or open flame.

Inactive Ingredients:

Water, isopropyl alcohol, herbal extract (IIex paraguariensis), menthol, carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FDandC blue #1

Package Labeling:

PainRelievingGelA

PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37205-824
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
TROLAMINE (UNII: 9O3K93S3TK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37205-824-261 in 1 CARTON01/18/2012
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/18/2012
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services LLC557434805manufacture(37205-824)

Revised: 10/2019
 
Cardinal Health


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