Ultra Blue

Manufacturer
BNG Enterprises DBA Herbal Clean | Personal Care Performance Group
Effective date
2019-04-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:17

Label at a glance#

ProductUltra Blue
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, sprains, strains, bruises.

Dosage and administration

• Adults and children 2 years and older, apply directly to affected area; not more than 3 or 4 times daily • Children under 2 years, ask a doctor

Label contents#

Full prescribing information#

Active ingredient section

OTC - ACTIVE INGREDIENT SECTION

Menthol (4%)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, sprains, strains, bruises.

Warnings

WARNINGS SECTION

For external use only.

Stop Use and Ask a Doctor If

OTC - STOP USE SECTION

• Condition worsens

• Symptoms last more than 7 days or clear up and occur again within a few days

• A rash or irritation develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When Using This Product

OTC - WHEN USING SECTION

• Do not apply to wounds or damaged skin

• Do not bandage tightly

• Do not use in or near the eyes; if product gets into eyes, rinse thoroughly with water

• Do not use with electric heating pad

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years and older, apply directly to affected area; not more than 3 or 4 times daily

• Children under 2 years, ask a doctor

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Purified Water, Propylene Glycol, Emu Oil, Methylsulfonylmethane (msm), Polyacrylamide (and) C13-14 Isoparaffin and Laureth-7, C12-15 Alkyl Benzoate, Dimethicone, Dioctyl Adipate (and) Octyl Stearate (and) Octyl Palmitate, White Willow Extract, Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben, Aloe Vera Gel, Panthenol, Ascorbic Acid, Capsicum Oleoresin, Cornflower Extract, Chamomile Extract, Feverfew Extract, Hypericum Extract, Calendula Extract, Linden Extract, Coriander Oil, Grape Seed Extract, Benzophenone-4, Polysorbate-20, Tetrasodium EDTA, Citric Acid, Fragrance, F D & C Blue #1 Lake

Ultra Blue tube front panel, back panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultra Blue TubeUltra Blue Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN3
415974menthol 0.04 MG/MG Topical GelSCD3
415974menthol 4 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70632-825-042021-01-29C16284748780-1ba0f9c33-2674-a910-e053-dadaa90a0b8560bab646-6712-43eb-e053-2a91aa0ac939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70632-825-04Ultra Blue5000 g in 1 TUBEGEL50003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70632-825ULTRA BLUE (4% MENTHOL) GEL [BNG ENTERPRISES DBA HERBAL CLEAN]3Legacy NDC, 1 package rows20190420_60bab646-6712-43eb-e053-2a91aa0ac939.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70632-82570632-825-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
EMU OIL344821WD61IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

Source Document#

Source XML

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
86e806a0-09fa-49b1-e053-2991aa0aa23560bab646-6712-43eb-e053-2a91aa0ac9392019-04-19WarningsExact identifier
spl id: 86e806a0-09fa-49b1-e053-2991aa0aa235
spl set id: 60bab646-6712-43eb-e053-2a91aa0ac939

Reported adverse events (FAERS/openFDA)#

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