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.

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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 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)

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