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NDC 00363-0874-25 Walgreens Cold Pain Relief 40 mg/mL Details

Walgreens Cold Pain Relief 40 mg/mL

Walgreens Cold Pain Relief is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens, Co. The primary component is MENTHOL.

Product Information

NDC	00363-0874
Product ID	0363-0874_ba9bd5cd-037d-4b0c-e053-2a95a90a332e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Walgreens Cold Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
Labeler Name	Walgreens, Co
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 00363-0874-25 (00363087425)

Pricing Information	N/A
NDC Package Code	0363-0874-25
Billing NDC	00363087425
Package	74 mL in 1 BOTTLE (0363-0874-25)
Marketing Start Date	2018-02-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6518a1e4-0ed2-e3ea-e053-2991aa0abb16 Details

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:0363-0874
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0874-25	74 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/06/2018

Labeler - Walgreens, Co (008965063)

Revised: 2/2021

Document Id: ba9bd5cd-037d-4b0c-e053-2a95a90a332e

Set id: 6518a1e4-0ed2-e3ea-e053-2991aa0abb16

Version: 3

Effective Time: 20210205