BOUQUET COOLING FORMULA- menthol roll-on liquid

Bouquet Cooling Formula by

Drug Labeling and Warnings

Bouquet Cooling Formula by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: Menthol 5%

PURPOSE

Purpose Topical Analgesic

INDICATIONS & USAGE

Uses

For the temporary relief of minor aches and pains associated with sore muscles, joint discomfort, strains, sprains and arthritis

WARNINGS

Warnings

For external use only. Consult a doctor before using if you are pregnant or breastfeeding.

WHEN USING

When using this product

• 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.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

Directions

Adults and children 2 years of age or older: Most effective when applied to the affected, and importantly, the surrounding areas. Light roll on and reapply after 30 seconds. For optimum results, repeat 4 times daily for 3 to 5 days.

INACTIVE INGREDIENT

Inactive Ingredients:

Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hydroxyethyl Cellulose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Sulfate, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel), Terpenes: alpha-Bisabolol, caryophyllene, alpha-humulene

QUESTIONS

QUESTIONS?

Contact us at info@bouquetcbd.com

MANUFACTURED FOR

Bouquet Brands LLC

1735 Market St. Suite 2501

Philadelphia PA 19103

For more information, please visit BouquetCBD.com

STORAGE AND HANDLING

STORAGE

Store in a cool, dry place, up to 77° F (25° C). Keep out of direct sunlight.

STATEMENT OF IDENTITY

PRODUCT BOX

PRINCIPAL DISPLAY PANEL

BOUQUET TOPICAL ROLL ON LABEL

INGREDIENTS AND APPEARANCE

BOUQUET COOLING FORMULA 
menthol roll-on liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-460
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.2 g  in 84 g

Inactive Ingredients
Ingredient Name	Strength
CANNABIDIOL (UNII: 19GBJ60SN5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
CARYOPHYLLENE (UNII: BHW853AU9H)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LOBELIA INFLATA (UNII: 9PP1T3TC5U)
WITCH HAZEL (UNII: 101I4J0U34)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
WATER (UNII: 059QF0KO0R)
GRAPEFRUIT (UNII: O82C39RR8C)
HUMULENE (UNII: 54W56MD2WD)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-460-03	1 in 1 BOX	12/09/2019
1	NDC: 76348-460-01	84 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/09/2019

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-460)