NEUROFREEZE- menthol liquid

NeuroFreeze by

Drug Labeling and Warnings

NeuroFreeze by is a Otc medication manufactured, distributed, or labeled by Blue Heron Pharmaceuticals, LLC, SOMBRA COSMETICS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Menthol 6%

Purposes:

Topical Analgesic

Uses:

Temporary relief of minor aches and pains of muscles and joints associated with:

• Strains
• Bruises
• Sprains

Directions: Adults and children 2 years of age and older:

Apply to affected area not more then 3 to 4 times daily.
Rub thoroughly until gel is absorbed.
For children under 2 years of age: Ask a doctor.

Warnings:

For external use ONLY. 

Do not use on wounds or damaged skin or with a heat source. If pregnant or breastfeeding, ask a healthcare professional before use.

When using this product:

• Avoid bandaging tightly
• Avoid contact with eyes
• Keep out of the reach of children

Stop use and ask doctor if:

• Condition worsens
• Symptoms persist for more than 7 days

Keep out of reach of children

If put in mouth, get medical help or contact a poison control center right away. Dispose of used product away from children and pets.

Storage:

• Store at 68-77℉ (20-25℃) - Room Temperature
• Do not exceed 100 oF (38 oC)

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Leaf Extract, Caprylyl Glycol, Carbomer, Citrus Grandis (Grapefruit) Seed Extract, Citrus Limon (Lemon) Peel Oil, Decyl Glucoside, Filipendula Ulmaria (Queen of the Prairie) Flower Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Phenoxyethanol, Purified Water, Rosa Damascena Flower Water, Sodium Carbonate, Yucca Schidigera Stem Extract.

SPL UNCLASSIFIED SECTION

Manufactured for:
Blue Heron Pharmaceuticals, LLC
2831 Allegra Way, Suite 218
Lutz, FL 33559

Questions or concerns call 813-380-0271

www.blueheronpharma.com

Packaging:

INGREDIENTS AND APPEARANCE

NEUROFREEZE 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85622-511
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER (UNII: 0A5MM307FC)
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL (UNII: AKN3KSD11B)
CITRUS LIMON (LEMON) PEEL OIL (UNII: I9GRO824LL)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
SODIUM CARBONATE (UNII: 45P3261C7T)
YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85622-511-85	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	02/23/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/23/2026

Labeler - Blue Heron Pharmaceuticals, LLC (137019051)

Establishment
Name	Address	ID/FEI	Business Operations
SOMBRA COSMETICS INC.		097464309	manufacture(85622-511) , label(85622-511)