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SUB-ZERO COOL PAIN RELIEVING

Dosage form: gel
Ingredients: MENTHOL 3.9g in 100mL
Labeler: CURRENT SOLUTIONS LLC
NDC Code: 61611-107

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 INGREDIENTS

NATURAL MENTHOL 3.9%

PURPOSE

COOLING PAIN RELIEF

USES

TEMPORARY RELIEF OF

  • ARTHRITIS
  • BACKACHE
  • STRAINS
  • SPRAINS

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, CUTS, RASHES, AND SORES. IF CONTACT OCCURS, FLUSH WITH COLD WATER.

DO NOT USE WITH HEATING PAD OR DEVICE, OR UNDER BANDAGE.

DO NOT USE IF PREGNANT OR BREAST FEEDING. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE.

DO NOT APPLY TO WOUNDS OR DAMAGED SKIN.

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

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: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY
  • RUB IN THOROUGHLY UNTIL IT IS ABSORBED.

INACTIVE INGREDIENTS

WATER, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, GLYCERINE, CARBOMER, ILEX PARAGUARIENSIS LEAF EXTRACT, HYDRATED SILICA, AMINOMETHYL PROPANOL, METHYL PARABEN, UNCARIA TOMENTOSA EXTRACT, BOSWEILA SERRATA EXTRACT, CAMPHOR FOR SCENT

SUB-ZERO  COOL PAIN RELIEVING
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61611-107
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
GLYCERIN 
CARBOMER 940 
ILEX PARAGUARIENSIS LEAF 
HYDRATED SILICA 
AMINOMETHYLPROPANOL 
METHYLPARABEN 
UNCARIA TOMENTOSA LEAF 
BOSWELLIA SERRATA RESIN OIL 
CAMPHOR OIL 
Packaging
#Item CodePackage Description
1NDC:61611-107-16473 mL in 1 BOTTLE
2NDC:61611-107-283785 mL in 1 BOTTLE
3NDC:61611-107-04118 mL in 1 TUBE
4NDC:61611-107-0388.8 mL in 1 BOTTLE
5NDC:61611-107-015 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/29/2013
Labeler - CURRENT SOLUTIONS LLC (831718965)

Revised: 01/2014
 
CURRENT SOLUTIONS LLC

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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