PROZERO- menthol gel 
RLABS, LLC

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RLABS (as PLD) - PROZERO (70585-111) - DELIST

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 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 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.

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

Keep out of reach of children.

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)

ProZero

PROZERO 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70585-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70585-111-055 mL in 1 TUBE; Type 0: Not a Combination Product08/09/201612/31/2023
2NDC:70585-111-34100 mL in 1 TUBE; Type 0: Not a Combination Product08/09/201612/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/09/201612/31/2023
Labeler - RLABS, LLC (080198106)

Revised: 4/2024
 
RLABS, LLC