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Dollar General Cold-Hot Medicated Patches

Dosage form: patch
Ingredients: MENTHOL 5g
Labeler: DOLGENCORP, LLC
NDC Code: 55910-972

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.

Dollar General Cold-Hot Medicated Patches

ACTIVE INGREDIENT

Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic

INACTIVE INGREDIENT

Glycerol, Sodium Polyacrylate, Water, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium
Dioxide, Kaolin, Tween 80, Propylene Glycol, Span 80, Tartaric Acid, PVP, Polyacrylic Acid

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control

INDICATIONS & USAGE

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis
■ muscle strains ■ muscle sprains ■ bruises ■ cramps

WARNINGS

For External Use Only.

DOSAGE & ADMINISTRATION

Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.

Wear one patch up to 8 hours. Repeat as necessary, but no more than 4 times daily. Reseal pouch after opening.

Children 12 years or younger: Consult a physician.

PURPOSE

Topical Analgesic

When using this product

Use only as directed ■ Don’t bandage tightly or use with heating pad
■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin.

Stop use and ask a doctor

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

If pregnant or breastfeeding

ask a health professional before use.

DIST. BY
Dolgencorp, LLC
100 Mission Ridge
Goodlettsville, TN 37072

DOLLAR GENERAL COLD-HOT MEDICATED PATCHES 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-972
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
SODIUM POLYACRYLATE (2500000 MW) 
DIHYDROXYALUMINUM AMINOACETATE 
WATER 
METHYLPARABEN 
PROPYLPARABEN 
TITANIUM DIOXIDE 
KAOLIN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SORBITAN MONOOLEATE 
TARTARIC ACID 
POVIDONES 
POLYACRYLIC ACID (250000 MW) 
Packaging
#Item CodePackage Description
1NDC:55910-972-056 POUCH in 1 BOX
11 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2017
Labeler - DOLGENCORP, LLC (068331990)
Establishment
NameAddressID/FEIOperations
Beijing HKKY Medical544434817manufacture(55910-972)

Revised: 10/2017
 
DOLGENCORP, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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