Holus Relief Cream by Nemadji Management, LLC

Holus Relief Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

HOLUS RELIEF CREAM- menthol, camphor cream 
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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DESCRIPTION

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

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

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

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

WARNINGS, Holus Relief Cream

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

IF PREGNANT OR BREASTFEEDING, SEE PHYSICIAN BEFORE USE

INACTIVE INGREDIENTS

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

HOLUS RELIEF CREAM 
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73278-210
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
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
WILLOW BARK (UNII: S883J9JDYX)
GLYCERIN (UNII: PDC6A3C0OX)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCOA BUTTER (UNII: 512OYT1CRR)
RICE BRAN OIL (UNII: LZO6K1506A)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
JOJOBA OIL (UNII: 724GKU717M)
CANNABIDIOL (UNII: 19GBJ60SN5)
AVOCADO OIL (UNII: 6VNO72PFC1)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEPPERMINT OIL (UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	white (White to slightly off-white, opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73278-210-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/24/2023
2	NDC: 73278-210-04	118 g in 1 CONTAINER; 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(73278-210)

Revised: 4/2023

Document Id: f9b1210d-e8c1-2863-e053-6394a90a27c4

34390-5

Set id: f9b1210d-e8c0-2863-e053-6394a90a27c4

Version: 1

Effective Time: 20230419