RELIADERM- methyl salicylate, menthol, capsaicin cream

Reliaderm by

Drug Labeling and Warnings

Reliaderm by is a Otc medication manufactured, distributed, or labeled by Icon Health Services, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Methyl Salicylate 25.00%

Menthol 10.00%

Capsaicin 0.035%

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.

• 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. Children under two, consult a physician.

Other 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: 69233-644
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETYL ALCOHOL (UNII: 936JST6JCN)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69233-644-03	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 - Icon Health Services, Llc (079435759)