SUB-ZERO COOL PAIN RELIEVING- menthol gel

SUB-ZERO by

Drug Labeling and Warnings

SUB-ZERO by is a Otc medication manufactured, distributed, or labeled by CURRENT SOLUTIONS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

NATURAL MENTHOL 3.9%

PURPOSE

PURPOSE

COOLING PAIN RELIEF

INDICATIONS & USAGE

USES

TEMPORARY RELIEF OF

• ARTHRITIS
• BACKACHE
• STRAINS
• SPRAINS

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

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

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUB-ZERO  COOL PAIN RELIEVING
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61611-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
UNCARIA TOMENTOSA LEAF (UNII: 487U8M3D2P)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
CAMPHOR OIL (UNII: 75IZZ8Y727)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61611-107-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/29/2013
2	NDC: 61611-107-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/29/2013
3	NDC: 61611-107-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	12/29/2013
4	NDC: 61611-107-03	88.8 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/29/2013
5	NDC: 61611-107-01	5 mL in 1 PACKET; Type 0: Not a Combination Product	12/29/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/29/2013

Labeler - CURRENT SOLUTIONS LLC (831718965)