PROZERO

Manufacturer
RLABS, LLC | HEALTHSPECIALTY
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:15:44

Label at a glance#

ProductPROZERO
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 5%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ProZeroProZero

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70585-11170585-111-05, 70585-111-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
150f1de0-6a2b-5f3d-e063-6294a90a645709025c0a-1214-41bf-acde-2695834da52a2024-04-01WarningsExact identifier
spl set id: 09025c0a-1214-41bf-acde-2695834da52a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.