Cold and Hot Medicated Pain Relief Large

Valu Merchandisers Company, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient
• Purpose
• Cold and Hot Medicated Pain Relief Large Uses
• Warnings
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Inactive ingredients
• package label

FULL PRESCRIBING INFORMATION

Active Ingredient

Purpose

Cold and Hot Medicated Pain Relief Large Uses

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

Warnings

For external use only

When using this product

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

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

Keep out of reach of children.

For use on children 12 years or younger consult a doctor. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• carefully remove backing from patch
  
• apply sticky side of patch to affected area
  
• repeat as necessary, but no more than 4 times daily

Inactive ingredients

2-ethylhexyl acrylate, acrylic acid, aluminium hydroxide, carboxymethylcellulose sodium, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate, sorbitan sesquioleate, starch, talc, tartaric acid, titanium oxide

package label

Cold and Hot Medicated Pain Relief Large Menthol PATCH Product Information Product Type Human otc drug label Item Code (Source) NDC:63941-949 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL 875 mg Inactive Ingredients Ingredient Name Strength ACRYLIC ACID aluminum hydroxide CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 polysorbate 80 water SORBITAN SESQUIOLEATE talc tartaric acid titanium dioxide Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 in 1 POUCH 2 NDC:63941-949-05 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part348 2011-09-12