Sugarloaf Menthol Revive Menthol Pain Cream

Sugarloaf Menthol Revive Menthol Pain Cream
SPL v2
SPL
SPL Set ID fa2f9539-b703-a00b-e053-6394a90ae309
Route
TOPICAL
Published
Effective Date 2023-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.9 g)
Inactive Ingredients
Cannabigerol Cannabichromene Peg-100 Stearate Water Glyceryl Monostearate Olive Oil Witch Hazel Shea Butter Laureth-7 Peppermint Oil C13-14 Isoparaffin White Wax Stearic Acid Coconut Oil Mangifera Indica Seed Butter Cannabis Sativa Seed Oil Corn Oil Cannabidiol Cetearyl Glucoside Phenoxyethanol Magnesium Sulfate, Unspecified Polyacrylamide (10000 Mw) Cetostearyl Alcohol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-25

Description

Menthol 5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For temporary relief of minor aches and pains associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Dosage and Administration

Instructions: Massage into skin until thoroughtly absorbed. Repeat as needed. Store at room temperature.

Description

Menthol 5%

Section 43683-2

Indications and Usage This is a clone of another product. Only slight changes to wording have happened. Nothing major.

Dosage and Administration - Directions were simplified.

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7

Do not bandage tightly

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use with heating pads or other heating devices.
Section 51727-6

Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil, with a proprietary blend of terpenes (alpha-bisabolol,

alpha-humulene, beta-caryophyllene, caryophyllene oxide, gualol, linalool),

Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Ethylhexylglycerin, Fragrance, Hemp-derived Cannabichromene (CBC), Cannabidiol (CBD), and Cannabigerol (CBG),

Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Sulfate, Mangifera Indica (Mango) Seed Buter,

Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid

Section 51945-4

REFERENCES:

Sugarloaf Organics Revive Menthol Pain Cream

Label and Box AUGUST 2025

Section 53413-1

Sugarloaf Organics

Drums, PA 18222

P: 570.866.5882

www.sugarloaforganic.com

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 5%


Structured Label Content

Indications and Usage (34067-9)

For temporary relief of minor aches and pains associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Dosage and Administration (34068-7)

Instructions: Massage into skin until thoroughtly absorbed. Repeat as needed. Store at room temperature.

Warnings and Precautions (34071-1)

For external use only

Section 43683-2 (43683-2)

Indications and Usage This is a clone of another product. Only slight changes to wording have happened. Nothing major.

Dosage and Administration - Directions were simplified.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

Do not bandage tightly

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use with heating pads or other heating devices.
Section 51727-6 (51727-6)

Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil, with a proprietary blend of terpenes (alpha-bisabolol,

alpha-humulene, beta-caryophyllene, caryophyllene oxide, gualol, linalool),

Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Ethylhexylglycerin, Fragrance, Hemp-derived Cannabichromene (CBC), Cannabidiol (CBD), and Cannabigerol (CBG),

Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Sulfate, Mangifera Indica (Mango) Seed Buter,

Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid

Section 51945-4 (51945-4)

REFERENCES:

Sugarloaf Organics Revive Menthol Pain Cream

Label and Box AUGUST 2025

Section 53413-1 (53413-1)

Sugarloaf Organics

Drums, PA 18222

P: 570.866.5882

www.sugarloaforganic.com

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 5%


Advanced Ingredient Data


Raw Label Data

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