PROZERO by RLABS, LLC / HEALTHSPECIALTY PROZERO- menthol gel

PROZERO by

Drug Labeling and Warnings

PROZERO by is a Otc medication manufactured, distributed, or labeled by RLABS, LLC, HEALTHSPECIALTY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

MENTHOL 5%

PURPOSE

TOPICAL ANALGESIC

USES

Temporarily relieves minor aches and pains of arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

When using this product: Use only as directed. Read and follow all directions and warnings on this label. Do not use with other sprays, ointments, creams, or liniments. Do not bandage or apply local heat (such as heating pads) or medicated patches to the area of use. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. A transient burning sensation may occur upon application but generally disappears in several days. Rare cases of serious burns have been reported
with products of this type.

STOP USE

Stop use and consult 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 you experience signs of skin injury, such as pain, swelling, or blistering where the product is applied.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, consult a healthcare professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

If swallowed, get medical help or contact a Poison Control Center right away. Store in a cool, dry place with the cap closed tightly and keep away from excessive heat or open flame.

DIRECTIONS

Adults and children over 12 years: Apply a thin layer to affected area.
Massage into painful area until thoroughly absorbed into skin.
AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.
Children 12 years or younger: Consult a doctor.

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Juice, Alcohol Denat., Arnica Montana Flower Oil, Propylene Glycol, Eucalyptus Globulus Leaf Oil, Mentha Arvensis (Horsemint) Leaf Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glucosamine, Dimethyl Sulfone, Tocopheryl Acetate, Lantana Camara (Sage) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Thymus Serpillum (Thyme) Leaf Extract, Glycereth-2 Cocoate, Pyridoxine HCL, Dimethylamino Methylpropanol, Benzoic Acid, Ethylhexylglycerin, Phenoxyethanol, CI 42090 (BLUE 1)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROZERO 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70585-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCOHOL (UNII: 3K9958V90M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLUCOSAMINE (UNII: N08U5BOQ1K)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LANTANA CAMARA LEAF (UNII: 90ZS0N560Y)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
DIMETHYLAMINE (UNII: ARQ8157E0Q)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70585-111-05	5 mL in 1 TUBE; Type 0: Not a Combination Product	08/09/2016
2	NDC: 70585-111-34	100 mL in 1 TUBE; Type 0: Not a Combination Product	08/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/09/2016

Labeler - RLABS, LLC (080198106)

Establishment
Name	Address	ID/FEI	Business Operations
HEALTHSPECIALTY		794053863	manufacture(70585-111)