Cool N Heat Well At Walgreens: Package Insert and Label Information

COOL N HEAT WELL AT WALGREENS- menthol spray
Walgreens

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.

Active ingredient Purpose

Menthol 16% Topical analgesic

Uses

• temporarily relief of pain and itching associated with:

• arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Warnings For external use only

Flammable

• do not use while smoking or near heat or flame
• avoid long term storage above 104​o F
• do not puncture or incinerate. Contents under pressure
• do not store at temperature above 120​o F

When using this product

• avoid contact with eyes and mucous membranes
• do not apply to wounds or damages skin
• do not bandage tightly
• use only as directed

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
•needed for longer than 1 week

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away

If pregnant or breast-feeding , ask a health professional before use.

Directions

• shake well
• adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
• children under 12 years of age: consult a doctor

Inactive ingredients

Glycerin, Propylene Glycol, SD Alcohol 40, Water

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COOL N HEAT WELL AT WALGREENS
menthol 16% spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3207
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 160 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin
Propylene Glycol
Alcohol
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-3207-04 118 mL in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/15/2013
Labeler — Walgreens (008965063)
Registrant — Product Quest Mfg (927768135)
Establishment
Name Address ID/FEI Operations
Product Quest Mfg 927768135 manufacture (0363-3207), label (0363-3207)

Revised: 02/2018 Walgreens

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