Pain Relieving: Package Insert and Label Information

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.

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
(click image for full-size original)

PAIN RELIEVING
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-824
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 35 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ISOPROPYL ALCOHOL
TROLAMINE
SILICON DIOXIDE
METHYLPARABEN
GLYCERIN
PROPYLENE GLYCOL
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37205-824-26 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (37205-824-26)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/18/2012
Labeler — Cardinal Health (097537435)
Establishment
Name Address ID/FEI Operations
Span Packaging Services LLC 117101131 manufacture (37205-824)
Establishment
Name Address ID/FEI Operations
Span Packaging Services LLC 557434805 manufacture (37205-824)

Revised: 11/2019 Cardinal Health

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