CVS EXTRA STRENGTH COLD AND HOT PAIN RELIEVING- menthol cream

CVS Extra Strength Cold and Hot Pain Relieving by

Drug Labeling and Warnings

CVS Extra Strength Cold and Hot Pain Relieving by is a Otc medication manufactured, distributed, or labeled by CVS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                         Purpose

Menthol 10%..................................................................Topical Analgesic

Methyl Salicylate 30%....................................................Topical Analgesic

PURPOSE

Uses temporarily relieves minor pain associated with:

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

WARNINGS

Warnings

• For external use only
• Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
  

WHEN USING

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes or mucous membranes
• do not apply to wounds, damaged, broken or irritated skin
  

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• irritation develops
  

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• Adults and children over 12 years:
• apply generously to affected area
• massage into painful area until thoroughly into skin
• repeat as necessary, but no more than 4 times daily
• close cap tightly after use
  
• keep carton as it contains important information
• Children 12 years or younger: Ask a doctor
  

INACTIVE INGREDIENT

Inactive ingredients DEA-cetyl phosphate, isopropyl myristate, lanolin, methylparaben, polysorbate 60, propylparaben, stearic acid, stearyl alcohol, trolamine, water

DOSAGE & ADMINISTRATION

Distributed By:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS EXTRA STRENGTH COLD AND HOT PAIN RELIEVING 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-469
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-469-09	1 in 1 CARTON
1		85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/13/2014

Labeler - CVS (062312574)