INSPIRATION ACADEMY MENTHOL COOLING PAIN CREAM- menthol 5 percent cream 
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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Inspiration Academy Menthol Cooling Pain Relief Cream

Active Ingredients:

Menthol 5%

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away.

Purpose

Topical Analgesic

Questions or Comments

PHONE: (941) 795-5466 (LION)

Stop use and ask a doctor if

condition worsens or if symptoms persist for more than seven days or clear up and occur again within a few days

When using this product:

Directions:

adults and children 12 years of age and older

Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter,

Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water,

Emulsifying Wax, Fragrance, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil,

Laureth-7, Lobelia Inflata (Lobelia) Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Leaf Oil, Olea europaea (Olive) Oil,

Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Xanthan Gum.

Uses:

for temporary relief of minor aches and pains associated with sore muscles, joint discomfort, strains, sprains, bruises and arthritis.

For external use only

IA BOX ARTPACKAGE LABEL AND BOX ART

IA Cream Label

INSPIRATION ACADEMY MENTHOL COOLING PAIN CREAM 
menthol 5 percent cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.6 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
PEG-100 STEARATE (UNII: YD01N1999R)  
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
WITCH HAZEL (UNII: 101I4J0U34)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
COCONUT OIL (UNII: Q9L0O73W7L)  
LAURETH-7 (UNII: Z95S6G8201)  
LOBELIA INFLATA (UNII: 9PP1T3TC5U)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CORN OIL (UNII: 8470G57WFM)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MAGNESIUM OROTATE (UNII: GI96W46M5A)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-900-011 in 1 BOX11/08/2021
1NDC:76348-900-04112 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/08/2021
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
RENU LABORATORIES, INC.945739449manufacture(76348-900)

Revised: 1/2022
Document Id: d04e5e54-6b8b-c7cb-e053-2a95a90aaf6e
Set id: d04e5e54-6b8a-c7cb-e053-2a95a90aaf6e
Version: 1
Effective Time: 20220103
 
Renu Laboratories, Inc.