Cooling Pain Relief 3% Menthol Cream

Cooling Pain Relief 3% Menthol Cream by

Drug Labeling and Warnings

Cooling Pain Relief 3% Menthol Cream by is a Otc medication manufactured, distributed, or labeled by Bluebird Botanicals, Royal Labs Natural Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COOLING PAIN RELIEF 3% MENTHOL CREAM- menthol 3% cream 
Bluebird Botanicals

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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Cooling Pain Relief 3% Menthol Cream

Menthol 3%

Menthol 3%......................Topical Analgesic

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

For external use only.

Do not use:

• on wounds or damaged skin
• on mouth or eyes
• with a heating pad
• on genitals or any other mucous membrane
• if condition worsens

Stop use and ask a doctor if:

• irritation occurs
• symptoms persist for more than 7 days, or clear up and recur

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

Adults 18 years of age and older: Apply one pump (serving) directly onto affected area 3 to 4 times daily; Children under 18 years of age ask a doctor.

Store in a cool dry place with lid closed tightly.

Aqua, Shea (Butyrospermum Parkii) Butter, Cetearyl Glucoside, Cetearyl Alcohol, Glyceryl Stearate Citrate, CBD (Cannabidiol) Isolate (from hemp (Cannabis sativa)), Organic Aloe Vera (Aloe Barbadensis) Leaf Juice, Tapioca Starch, Glycerin, Caprylic/Capric Triglyceride, Xanthan Gum, Organic Rosemary (Rosmarinus Officinalis) Leaf Extract, Organic Arnica (Arnica Spp.) Extract, Glyceryl Caprylate, Caprylhydroxamic Acid, Citric Acid

Bluebird Botanicals

Cooling Pain Relief

3% Menthol Cream

CBD: 10 mg Per Pump

CBD: 500 mg Per Bottle

Net wt. 1.7 oz (50 mL)

Made with moisturizing Shea Butter, Aloe & CBD*

COOLING PAIN RELIEF 3% MENTHOL CREAM 
menthol 3% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81525-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CANNABIDIOL (UNII: 19GBJ60SN5)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ARNICA MONTANA (UNII: O80TY208ZW)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STARCH, TAPIOCA (UNII: 24SC3U704I)
TRICAPRIN (UNII: O1PB8EU98M)
ROSEMARY (UNII: IJ67X351P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81525-001-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/17/2021	12/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/17/2021	12/16/2021

Labeler - Bluebird Botanicals (047958622)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Labs Natural Cosmetics, Inc.		197478480	manufacture(81525-001)

Revised: 12/2021

Document Id: d34f59ab-ab75-48b2-e053-2a95a90ada0b

34390-5

Set id: bd496670-8c63-4f17-e053-2a95a90a76f1

Version: 2

Effective Time: 20211216