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PROZERO

Medically reviewed on August 9, 2016

Dosage form: gel
Ingredients: MENTHOL 5g in 100mL
Labeler: RLABS, LLC
NDC Code: 70585-111

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 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 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70585-111
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALCOHOL 
ARNICA MONTANA FLOWER 
PROPYLENE GLYCOL 
EUCALYPTUS GLOBULUS LEAF 
MENTHA ARVENSIS LEAF OIL 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
GLUCOSAMINE 
DIMETHYL SULFONE 
.ALPHA.-TOCOPHEROL ACETATE 
LANTANA CAMARA LEAF 
ROSMARINUS OFFICINALIS WHOLE 
THYMUS SERPYLLUM 
GLYCERETH-2 COCOATE 
PYRIDOXINE HYDROCHLORIDE 
DIMETHYLAMINE 
BENZOIC ACID 
ETHYLHEXYLGLYCERIN 
PHENOXYETHANOL 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:70585-111-055 mL in 1 TUBE
2NDC:70585-111-34100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/09/2016
Labeler - RLABS, LLC (080198106)
Establishment
NameAddressID/FEIOperations
HEALTH SPECIALTY794053863manufacture(70585-111)

 
RLABS, 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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