AMPLIFY RELIEF MM- methyl salicylate, menthol cream

AMPlify Relief MM by

Drug Labeling and Warnings

AMPlify Relief MM by is a Otc medication manufactured, distributed, or labeled by International Brand Management, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Methyl Salicylate....30.00%

Menthol.................10.00%

PURPOSE

Purpose

Topical Analgesic

Topical Analgesic

INDICATIONS & USAGE

Uses: temporarily relieves the minor aches and pains of muscles and joints associated with:

-simple backache  -arthritis   -strains   -bruises   -sprains

WARNINGS

Warnings:

For external use only

Do not use:

-on wounds or damaged skin     -with a heating pad

-on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area

WHEN USING

When using this product:

-avoid contact with eyes or mucous membranes

-do not bandage tightly

STOP USE

Stop use and ask a doctor if:

-condition worsens or symptoms persist for more than 7 days

-symptoms clear up and occur again within a few days

-excessive skin irritation occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or

contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Directions:

-use only as directed

-adults and children 12 years of age and older:

apply to affected area not more than 3 to 4 times daily

-children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),

Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Cannabis

Sativa (Hemp) Seed Oil, Cetearyl Olivate, Cetyl Alcohol, Chondrotin Sulfate, Gluconolactone,

Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Magnesium

Sulfate, Methylsulfonylmethane (MSM), Sodium Benzoate, Sodium Laurylglucosides

Hydroxypropylsulfonate, Sorbitan Olivate, Tapioca Starch, Xanthan Gum, Zemea (Corn)

Propanediol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMPLIFY RELIEF MM 
methyl salicylate, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69837-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	3 g  in 10 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
Cetearyl Olivate (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
Glucosamine Sulfate (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STARCH, TAPIOCA (UNII: 24SC3U704I)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69837-019-01	1 in 1 CARTON	01/17/2017
1	NDC: 69837-019-02	118 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/17/2017

Labeler - International Brand Management, LLC (079794940)

Establishment
Name	Address	ID/FEI	Business Operations
International Brand Management, LLC		079794940	manufacture(69837-019)