Search by Drug Name or NDC

NDC 72331-0328-00 Reliefor 60 mg/mL Details

Reliefor 60 mg/mL

Reliefor is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Systems Health, LLC. The primary component is MENTHOL.

Product Information

NDC	72331-0328
Product ID	72331-328_6cf675fd-981a-a854-e053-2a91aa0a1d62
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Reliefor
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	60
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
Labeler Name	Systems Health, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72331-0328-00 (72331032800)

Pricing Information	N/A
NDC Package Code	72331-328-00
Billing NDC	72331032800
Package	118 mL in 1 TUBE (72331-328-00)
Marketing Start Date	2018-05-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3f90f4d8-b906-4283-a02a-d696d9f77e5d Details

Drug Facts

Active Ingredient

Menthol USP 6%

Purpose

External Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

• arthritis • strains • bruises • sprains • joint discomfort

Warnings:

For external use only. Avoid contact with eyes.

Do not use

on wounds, damaged skin, or irritated areas
a heating pad in area where product is applied

When using this product:

use only as directed
avoid contact with eyes and mucous membranes
do not bandage or cover tightly
do not use with other topical products without first consulting a healthcare professional

Stop use and ask a doctor if:

conditions worsen, or if symptoms persist for more than 7 days
conditions clear up and occur again within a few days

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Directly massage into achy points of the body. Wash hands after use with cool water. Product will gradually activate and warm to provide long-lasting relief.
Children under 2 years of age: consult a doctor.

Inactive Ingredients :

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Boswellia Serrata Extract, Carbomer, Dimethicone, Dimethyl Sulfone (MSM), Disodium EDTA, Ethylhexylglycerin, FD&C Blue #1, Hydroxypropyl Methylcellulose, Oleth-10, Phenoxyethanol, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sorbitan Oleate, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water

Other Information:

Store in a cool, dry place with cap closed tightly.

Questions:

1-904-834-0S4H Systems4Health.com

Package Labeling:

INGREDIENTS AND APPEARANCE

RELIEFOR

menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72331-328
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
OLETH-10 (UNII: JD797EF70J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALMOND OIL (UNII: 66YXD4DKO9)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72331-328-00	118 mL in 1 TUBE; Type 0: Not a Combination Product	05/23/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/23/2018

Labeler - Systems Health, LLC (961404295)

Revised: 5/2018

Document Id: 6cf675fd-981a-a854-e053-2a91aa0a1d62

Set id: 3f90f4d8-b906-4283-a02a-d696d9f77e5d

Version: 1

Effective Time: 20180524