WALGREENS COLD PAIN RELIEF- menthol gel

Walgreens Cold Pain Relief by

Drug Labeling and Warnings

Walgreens Cold Pain Relief by is a Otc medication manufactured, distributed, or labeled by Walgreens, Co, Span Packaging Services LLC, Cosmetic Essence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Flammable: Keep away from excessive heat or open flame

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:

INGREDIENTS AND APPEARANCE

WALGREENS COLD PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0864
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0864-03	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2018

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	Business Operations
Span Packaging Services LLC		117101131	manufacture(0363-0864)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		825646862	manufacture(0363-0864)