Holus Relief Cream

Manufacturer
Nemadji Management, LLC
Effective date
2023-04-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:32:37

Label at a glance#

ProductHolus Relief Cream
Active ingredientMENTHOL, UNSPECIFIED FORM, CAMPHOR OIL
Label structure6 sections

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Holus Relief Cream, 1.7 oz - menthol, camphor cream

Holus Relief Cream, 4 oz - menthol, camphor cream

Topical analgesic, Over-The-Counter drug

1.7 ounces of topical analgesic cream in a pump dispenser

4 ounces of topical analgesic cream in a container

Disclaimer: Most OTC drugs are not reviewed and approved by the FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 3.9%

CAMPHOR 0.4%

PURPOSE

OTC - PURPOSE SECTION

FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH SIMPLE BACKACHE, ARTHRITIS, STRAINS, BRUISES AND SPRAINS.

DIRECTIONS

INDICATIONS & USAGE SECTION

APPLY TO INFLAMED & SORE AREA NO MORE THAN 3-4 TIMES PER DAY. ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER; CHILDREN UNDER 2 YEARS OF AGE: CONSULT A PHYSICIAN.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

APPLY TO INFLAMED & SORE AREA NO MORE THAN 3-4 TIMES PER DAY.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

AVOID CONTACT WITH EYES

DO NOT APPLY: TO WOUNDS OR DAMAGED SKIN

ALLERGY: PRODUCT CONTAINS COCONUT

THE SAFETY OF THIS PRODUCT HAS NOT BEEN DETERMINED.

THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNINGS, Holus Relief Cream

BOXED WARNING SECTION

STOP AND ASK A PHYSICIAN (IF CONDITION WORSENS, SYMPTOMS PERSIST MORE THAN 7 DAYS, CONDITION RECURS AFTER A FEW DAYS).

WARNING - PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

IF PREGNANT OR BREASTFEEDING, SEE PHYSICIAN BEFORE USE

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

PURIFIED WATER, SHEA BUTTER, UNREFINED COCONUT OIL, STEARIC ACID, WILLOW BARK EXTRACT,CETYL PALMITATE,

JOJOBA OIL, COCOA BUTTER, ARNICA EXTRACT, SUNFLOWER OIL, GLYCERYL STEARATE, VITAMIN E ACETATE, GRAPESEED OIL, AVOCADO OIL, MSM (METHYLSULFONYLMETHANE), RICE BRAN OIL, XANTHAN GUM, SORBIC ACID, GLYCERIN, TETRASODIUM GLUTAMATE DIACETATE, SODIUM BENZOATE, SODIUM HYDROXIDE, CITRIC ACID, PEPPERMINT OIL, HEMP EXTRACT, BOSWELLIA SERRATA EXTRACT.

PRICIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

observationMediaobservationMediaobservationMediaobservationMedia

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73278-21073278-210-50, 73278-210-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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
f9b1210d-e8c1-2863-e053-6394a90a27c4f9b1210d-e8c0-2863-e053-6394a90a27c42023-04-19Boxed warning, WarningsExact identifier
spl id: f9b1210d-e8c1-2863-e053-6394a90a27c4
spl set id: f9b1210d-e8c0-2863-e053-6394a90a27c4

Reported adverse events (FAERS/openFDA)#

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