Walgreens Cold Pain Relief: Package Insert and Label Information

WALGREENS COLD PAIN RELIEF- menthol gel
Walgreens, Co

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

Menthol 4%

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

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 • Store in a cool dry place.

Stop use and ask a doctor if:

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

If pregnant or breast-feeding:

Ask a health professional before use

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

Adults and Children 2 years of age and older: rub a thin film over affected areas not more than four times daily; massage not necessary.
Children under 2 years of age: Consult physician

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

Questions or Comments:

1-800-925-4733

Package Labeling:

Bottle
(click image for full-size original)

WALGREENS COLD PAIN RELIEF
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0864
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
ARCTIUM LAPPA ROOT
ARNICA MONTANA FLOWER
FD&C BLUE NO. 1
FRANKINCENSE
CALENDULA OFFICINALIS FLOWER
GREEN TEA LEAF
CARBOXYPOLYMETHYLENE
GLYCERIN
ILEX PARAGUARIENSIS LEAF
ISOPROPYL ALCOHOL
ISOPROPYL MYRISTATE
MELISSA OFFICINALIS LEAF
SILICON DIOXIDE
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
WATER
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0864-03 89 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/06/2018
Labeler — Walgreens, Co (008965063)
Establishment
Name Address ID/FEI Operations
Span Packaging Services LLC 117101131 manufacture (0363-0864)
Establishment
Name Address ID/FEI Operations
Cosmetic Essence, LLC 825646862 manufacture (0363-0864)

Revised: 02/2021 Walgreens, Co

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