Reliefor by Systems Health, LLC RELIEFOR- menthol cream

Reliefor by

Drug Labeling and Warnings

Reliefor by is a Otc medication manufactured, distributed, or labeled by Systems Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Systems Health, LLC (961404295)