BOUQUET COOLING FORMULA- menthol roll-on liquid
Renu Laboratories, Inc.

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.

----------

BOUQUET ROLL-ON

Active ingredient: Menthol 5%

Purpose Topical Analgesic

Uses

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

Warnings

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

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 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

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

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 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?

MANUFACTURED FOR

Bouquet Brands LLC

1735 Market St. Suite 2501

Philadelphia PA 19103

For more information, please visit BouquetCBD.com

STORAGE

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

PRODUCT BOX

3oz rollon Box

BOUQUET TOPICAL ROLL ON LABEL

3oz Roll on Label

BOUQUET COOLING FORMULA
menthol roll-on liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76348-460-03	1 in 1 BOX	12/09/2019	08/15/2022
1	NDC:76348-460-01	84 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/09/2019	08/15/2022

Labeler - Renu Laboratories, Inc. (945739449)

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

Revised: 8/2022

Document Id: e6d619af-3676-5412-e053-2a95a90aa96d

Set id: 99e901ad-1e3a-6ae6-e053-2995a90a5d9c

Version: 9

Effective Time: 20220822

Renu Laboratories, Inc.