INSPIRATION ACADEMY MENTHOL COOLING PAIN CREAM- menthol 5 percent cream

Inspiration Academy Menthol Cooling Pain Cream by

Drug Labeling and Warnings

Inspiration Academy Menthol Cooling Pain Cream by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc., RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Menthol 5%

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.

PURPOSE

Purpose

Topical Analgesic

QUESTIONS

Questions or Comments

PHONE: (941) 795-5466 (LION)

STOP USE

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

When using this product:

• Do not bandage tightly
• avoid contact with eye
• do not apply to wounds or damaged skin
• do not use heating pads or other heating devices.

DOSAGE & ADMINISTRATION

Directions:

adults and children 12 years of age and older

• apply generously to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary

INACTIVE INGREDIENT

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.

INDICATIONS & USAGE

Uses:

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

WARNINGS

For external use only

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL AND BOX ART

INGREDIENTS AND APPEARANCE

INSPIRATION ACADEMY MENTHOL COOLING PAIN CREAM 
menthol 5 percent cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.6 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-900-01	1 in 1 BOX	11/08/2021
1	NDC: 76348-900-04	112 g in 1 JAR; 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	11/08/2021

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-900)