AMPLIFY RELIEF MM- methyl salicylate, menthol cream 
International Brand Management, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active Ingredients:

Methyl Salicylate....30.00%

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

Purpose

Topical Analgesic

Topical Analgesic

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

-simple backache  -arthritis   -strains   -bruises   -sprains

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 this product:

-avoid contact with eyes or mucous membranes

-do not bandage tightly

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 to avoid accidental ingestion. If swallowed, get medical help or

contact a Poison Control Center immediately

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 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.

image description

AMPLIFY RELIEF MM 
methyl salicylate, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69837-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE3 g  in 10 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69837-019-011 in 1 CARTON01/17/2017
1NDC:69837-019-02118 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/17/2017
Labeler - International Brand Management, LLC (079794940)
Establishment
NameAddressID/FEIBusiness Operations
International Brand Management, LLC079794940manufacture(69837-019)

Revised: 3/2017
Document Id: 6b074006-0212-4147-a5fa-2b1b85b1fb1f
Set id: ef713a9f-4210-454c-8349-4f5e8b52000d
Version: 4
Effective Time: 20170313
 
International Brand Management, LLC