AMP RELIEF PAIN RELIEF CREAM- menthol cream 
COASTAL FORMULAS 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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AMP RELIEF Pain Relief Cream

Drug Facts

Active Ingredients

Menthol 8.00%

Purpose

Topical Analgesic

Uses:

Warnings:

For external use only.

Do not use 

  • on damaged or broken skin

When using thsi product 

  • Avoid contact with the eyes.
  • Do not bandage tightly.

Stop use and ask a doctor if

  • rash or irritation develops and lasts
  • condition worsens 
  • symptoms persist for more than 7 days 
  • clears up and occurs again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. 

If pregnant or breast-feeing,

ask a health professional before use

Directions:

Flammable:

Inactive ingredients:

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Isopropyl Myristate, Methyl Salicylate, Paraffinum Liquidum, Phenoxyethanol, Polysorbate-80, SD-Alcohol 40B Triethanolamine, FD&C Blue #1, FD&C Yellow #5

Questions?

1(888) 510-6289

Package Labeling:

Label

AMP RELIEF PAIN RELIEF CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82560-273
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82560-273-00118.29 mL in 1 TUBE; Type 0: Not a Combination Product02/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/15/2022
Labeler - COASTAL FORMULAS LLC (085954368)

Revised: 2/2022
Document Id: d7a783d4-0007-50a1-e053-2a95a90a222f
Set id: 39564c67-49ab-42d4-a391-792ac69180c0
Version: 1
Effective Time: 20220210
 
COASTAL FORMULAS LLC