BAE SCIENCES MENTHOL MUSCLE RUB- menthol muscle rub lotion

Bae Sciences Menthol Muscle Rub by

Drug Labeling and Warnings

Bae Sciences Menthol Muscle Rub by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol USP 5%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

Uses: for temporary relief of minor aches and pains of muscles and joints associated with deep-muscle therapy treatments.

WARNINGS

For external use only

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 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your health care provider.
• children under 12 years of age, consult your health care provider.

STATEMENT OF IDENTITY

Bae Sciences Menthol Muscle Rub

QUESTIONS

Manufactured for Bae Sciences

Miami, FL 33132

ph. 754-227-9222

Baesciences.com

INACTIVE INGREDIENT

Arnica Montana (Arnica) Extract, Butyrospermum Parkii (Shea) Butter, C13-14 Isoalkane, Cannabidiol, Cannabigerol, Cannabis Sativa (Hemp) Seed Oil, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, PEG-100 Stearate, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Laureth-7, Lobelia Inflata (Lobelia) Flower Extract, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Oil, Niacinamide, Olea Europaea (Olive) Fruit Oil, Olus (Vegetable) Oil, Polyacrylamide, Stearic Acid and a proprietary blend of terpenes, including alpha-bisabolol, alpha-humulene, alpha-pinene, alpha-terpinene, beta-caryophyllene, beta-myrcene, beta-pinene, caryophyllene oxide, cis-beta-ocimene, D-limonene, eucalyptol, gamma-terpinene, guaiol, linalool, menthol, p-cymene, terpinolene, trans-nerolidiol

PRINCIPAL DISPLAY PANEL

PRODUCT LABEL ART AND PRODUCT BOX ART

INGREDIENTS AND APPEARANCE

BAE SCIENCES MENTHOL MUSCLE RUB 
menthol muscle rub lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 95 g

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
NEROLIDOL (UNII: QR6IP857S6)
MYRCENE (UNII: 3M39CZS25B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CARYOPHYLLENE OXIDE (UNII: S2XU9K448U)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
P-CYMENE (UNII: 1G1C8T1N7Q)
CANNABIDIOL (UNII: 19GBJ60SN5)
STEARIC ACID (UNII: 4ELV7Z65AP)
OLIVE OIL (UNII: 6UYK2W1W1E)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
CARYOPHYLLENE (UNII: BHW853AU9H)
.BETA.-PINENE (UNII: 4MS8VHZ1HJ)
EUCALYPTOL (UNII: RV6J6604TK)
.GAMMA.-TERPINENE (UNII: 4YGF4PQP49)
SHEA BUTTER (UNII: K49155WL9Y)
CANNABIGEROL (UNII: J1K406072N)
WATER (UNII: 059QF0KO0R)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
COCONUT OIL (UNII: Q9L0O73W7L)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
HUMULENE (UNII: 54W56MD2WD)
.ALPHA.-PINENE (UNII: JPF3YI7O34)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CORN OIL (UNII: 8470G57WFM)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
.BETA.-OCIMENE, (3Z)- (UNII: 472UVP4R7T)
TERPINOLENE (UNII: N9830X5KSL)
WHITE WAX (UNII: 7G1J5DA97F)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
WITCH HAZEL (UNII: 101I4J0U34)
LAURETH-7 (UNII: Z95S6G8201)
ARNICA MONTANA (UNII: O80TY208ZW)
NIACINAMIDE (UNII: 25X51I8RD4)
GUAIOL (UNII: I7WP008A91)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-505-02	1 in 1 BOX	08/21/2023
1	NDC: 76348-505-01	95 g in 1 BOTTLE, GLASS; 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	08/21/2023

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-505)