TOPICAL ANALGESIC- menthol cream

Topical Analgesic by

Drug Labeling and Warnings

Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Youngevity International Inc., Creative Essences Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 1.4%, Purpose: Topical Analgesic

Purpose

Topical Analgesic

Uses

Temporary relief on minor aches and pains of sore muscles and joints associated with:

• Backaches
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Stop use and ask a doctor

Stop use and ask a doctor if

• condition worsens
• symptoms persists for more than 7 day or clears up and occurs again within a few days

When using this product

When using this product:

• Keep out of eyes, ears, and mouth
• In case of contact with eyes, rinse eyes thoroughly with water
• Do not apply to wounds or damaged skin
• Do not bandage tightly

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, apply to affected area no more than 3 to 4 times a day.

children under 2 years of age, consult a doctor.

Other information

Store in a cool, dry place

Inactive Ingredient

Carbomer, celadrin (cetyl myristoleate, cetyl myristate, cetyl palmitaoleate, cetyl oleate, cetyl laurate), cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl monostearate, myristyl alcohol, olive oil, peppermint oil, phenoxyethanol, polysorbate 20, propylene glycol, stearic acid, triethanolamine, water

PDP

Ultimate CM Cream Muscle and Joint Support 2 fl oz

INGREDIENTS AND APPEARANCE

TOPICAL ANALGESIC 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80986-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL TALLOWATE (UNII: MVY7P518D2)	1.56 g  in 100 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.12 g  in 100 g
STEARIC ACID (UNII: 4ELV7Z65AP)	3.5 g  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E)	5 g  in 100 g
PEPPERMINT OIL (UNII: AV092KU4JH)	0.7 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	1 g  in 100 g
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.5 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.5 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK)	0.07 g  in 100 g
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)	2.25 g  in 100 g
CETYL ALCOHOL (UNII: 936JST6JCN)	2.25 g  in 100 g
WATER (UNII: 059QF0KO0R)	72.65 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	5 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	3.5 g  in 100 g

Product Characteristics
Color	white (Cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80986-101-01	59 g in 1 JAR; Type 0: Not a Combination Product	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/30/2020

Labeler - Youngevity International Inc. (078524610)

Registrant - Creative Essences Inc (079120182)

Establishment
Name	Address	ID/FEI	Business Operations
Creative Essences Inc		079120182	manufacture(80986-101)