BAE SCIENCES MENTHOL MUSCLE RUB- menthol muscle rub lotion 
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.

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BAE SCIENCES MENTHOL MUSCLE RUB

Menthol USP 5%

Topical Analgesic

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

For external use only

When using this product:

Do not bandage tightly

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

Bae Sciences Menthol Muscle Rub

Manufactured for Bae Sciences

Miami, FL 33132

ph. 754-227-9222

Baesciences.com

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

PRODUCT LABEL ART AND PRODUCT BOX ART

Bae Box Art

Bae Product Label

BAE SCIENCES MENTHOL MUSCLE RUB 
menthol muscle rub lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-505
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 95 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-505-021 in 1 BOX08/21/2023
1NDC:76348-505-0195 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/21/2023
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-505)

Revised: 8/2023
Document Id: 03372376-ef07-943d-e063-6394a90a52ee
Set id: 03372376-ef06-943d-e063-6394a90a52ee
Version: 1
Effective Time: 20230818
 
Renu Laboratories, Inc.