MUSCLE FREEZE RELIEF- menthol gel 
NATURAL ESSENTIALS, INC.

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Drug Facts

SHAKE WELL

Active ingredient

Menthol 3.7%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

Warnings

For external use only.

Flammable:Keep away from fire or flame and heated surfaces

Do Not Use

  • if you are allergic to any ingredient in this product
  • on open wounds, damaged or irritated skin
  • with a heating pad or TENS device
  • after expiration date

When using this product

  • do not bandage tightly
  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes

Stop use and ask a doctor if

  • condition worsens
  • rash, itching, redness or excessive irritation of the skin develops
  • symptoms persist for more than 7 days
  • symptoms dear up and occur again within a few days

If pregnant or breastfeeding,ask a health professional before use.

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

  • apply to affected area no more than 4 times a day
  • massage painful area until absorbed into skin
  • wash hands after each use with cold water

Children under 12 years of age:consult a doctor.

Other Information

Inactive ingredients

Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, Carbomer, Ethylhexylglycerin, Ilex Paraguariensis leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.

Principal Display Panel – 85 g Container Label

Muscle
Freeze
Relief Gel

Net Wt. 3 oz. (85 g)

Muscle Freeze Relief Gel - 3 oz

Principal Display Panel – 425 g Container Label

Muscle
Freeze
Relief Gel

Net Wt. 15 oz. (425 g)

Muscle Freeze Relief Gel - 15 oz

Principal Display Panel - 113 g Container Label

Muscle

Freeze

Relief Gel

Net Wt. 4 oz (113 g) Muscle Freeze Gel - 4 oz

MUSCLE FREEZE RELIEF 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM37 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-410-0385 g in 1 CONTAINER; Type 0: Not a Combination Product07/15/2021
2NDC:66902-410-04113 g in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
3NDC:66902-410-16453 g in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
4NDC:66902-410-283629 g in 1 JUG; Type 0: Not a Combination Product07/15/2021
5NDC:66902-410-55195498 g in 1 DRUM; Type 0: Not a Combination Product07/15/2021
6NDC:66902-410-15425 g in 1 BOTTLE; Type 0: Not a Combination Product12/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/15/2021
Labeler - NATURAL ESSENTIALS, INC. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713manufacture(66902-410)

Revised: 10/2024
Document Id: 240d1402-4d06-62ff-e063-6294a90ad60c
Set id: 815c534b-096d-49f2-b5f2-8c885d45a5e6
Version: 3
Effective Time: 20241009
 
NATURAL ESSENTIALS, INC.