RELIADERM- methyl salicylate, menthol, capsaicin cream

Reliaderm by

Drug Labeling and Warnings

Reliaderm by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Methyl Salicylate 25.00%
Menthol 10.00%
Capsaicin 0.035%

PURPOSE

Topical Analgesic

Uses:

For temporary relief of minor aches and pains associated with simple backache, arthritis, bruises and sprains.

Warnings:

• For external use only.
• Avoid contact with eyes and mucous membranes.
• Do not bandage tightly or cover treated areas.
• Do not use with heating pad.
• Do not apply to open wounds or damaged skin.
• A mild burning sensation may occur. If severe burning sensation occurs, discontinue use immediately.
• If symptoms persist for more than seven days, discontinue use and consult a physician.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children. If swallowed, consult physician.
• If pregnant or breast feeding, contact physician prior to use.

Directions For Adults:

Apply directly to effected area. Repeat as necessary, but do not use more than 3-4 times daily.

Inactive Ingredients

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Phenoxyethanol, Sodium Lauryl Sulfate, Stearic Acid, Triethanolamine.

Package Labeling:

INGREDIENTS AND APPEARANCE

RELIADERM 
methyl salicylate, menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-644
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	25 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.035 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-644-03	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/24/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/25/2014

Labeler - Pure Source, LLC (080354456)