MUSCLE FREEZE RELIEF- menthol gel

Muscle Freeze Relief by

Drug Labeling and Warnings

Muscle Freeze Relief by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• Simple backache
• Arthritis
• Strains
• Bruises
• Sprains

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

• store in a cool place away from direct sunlight
• store with cap closed tightly

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)

Principal Display Panel – 425 g Container Label

Muscle
Freeze
Relief Gel

Net Wt. 15 oz. (425 g)

Principal Display Panel - 113 g Container Label

Muscle

Freeze

Relief Gel

Net Wt. 4 oz (113 g)

INGREDIENTS AND APPEARANCE

MUSCLE FREEZE RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	37 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-410-03	85 g in 1 CONTAINER; Type 0: Not a Combination Product	07/15/2021
2	NDC: 66902-410-04	113 g in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2021
3	NDC: 66902-410-16	453 g in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2021
4	NDC: 66902-410-28	3629 g in 1 JUG; Type 0: Not a Combination Product	07/15/2021
5	NDC: 66902-410-55	195498 g in 1 DRUM; Type 0: Not a Combination Product	07/15/2021
6	NDC: 66902-410-15	425 g in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/15/2021

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	manufacture(66902-410)