Holus Relief Gel, 1.7 oz by Nemadji Management, LLC HOLUS RELIEF GEL, 1.7 OZ

Holus Relief Gel, 1.7 oz by

Drug Labeling and Warnings

Holus Relief Gel, 1.7 oz by is a Otc medication manufactured, distributed, or labeled by Nemadji Management, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HOLUS RELIEF GEL, 1.7 OZ- menthol, camphor gel 
Nemadji Management, LLC

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.

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HOLUS RELIEF GEL, 1.7 OZ

DESCRIPTION

Holus Relief Gel, 1.7oz - menthol, camphor gel

Topical analgesic, Over-The-Counter drug

1.7oz ounces of topical analgesic gel in a pump dispenser

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

MENTHOL 3.9%

CAMPHOR 0.4%

PURPOSE

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

DIRECTIONS, Holus Relief Gel, 1.7oz

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 SECTION

Apply to inflamed & sore area no more than 3-4 times per day.

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

WARNINGS, Holus Relief Gel, 1.7oz

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

IF PREGNANT OR BREASTFEEDING, SEE PHYSICIAN BEFORE USE

INACTIVE INGREDIENTS, Holus Relief Gel (1.7oz)

PURIFIED WATER, ISOPROPYL ALCOHOL, WITCH HAZEL, ALOE VERA GEL, COCONUT OIL, JOJOBA OIL, GLYCERIN, ARNICA EXTRACT, BOSWELLIA SERRATA EXTRACT, MSM (METHYLSULFONYLMETHANE), CARBOMER, VITAMIN E ACETATE, TETRASODIUM GLUTAMATE DIACETATE, SODIUM BENZOATE, SODIUM HYDROXIDE, CITRIC ACID, PEPPERMINT OIL, EUCALYPTUS OIL, WILLOW BARK EXTRACT, HEMP EXTRACT (AERIAL PARTS, 222MG)

PRINCIPAL DISPLAY

HOLUS RELIEF GEL, 1.7 OZ 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73278-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	3.9 g  in 100 g
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)	CAMPHOR OIL	0.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CANNABIDIOL (UNII: 19GBJ60SN5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JOJOBA OIL (UNII: 724GKU717M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WITCH HAZEL (UNII: 101I4J0U34)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
COCONUT OIL (UNII: Q9L0O73W7L)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WILLOW BARK (UNII: S883J9JDYX)
GLYCERIN (UNII: PDC6A3C0OX)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)

Product Characteristics
Color	white (transparent gel)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73278-202-50	50 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/24/2023
2	NDC: 73278-202-03	90 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	04/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/24/2023

Labeler - Nemadji Management, LLC (100279564)

Registrant - Nemadji Management, LLC (100279564)

Establishment
Name	Address	ID/FEI	Business Operations
Nemadji Management, LLC		100279564	manufacture(73278-202)

Revised: 4/2023

Document Id: f9b38271-4d8c-a628-e053-6394a90ac853

34390-5

Set id: f667d5bf-5e08-0626-e053-2995a90a6fa6

Version: 2

Effective Time: 20230419