PHIZICO PAIN RELIEF- menthol cream

PHIZICO Pain Relief by

Drug Labeling and Warnings

PHIZICO Pain Relief by is a Otc medication manufactured, distributed, or labeled by ER3 BRANDS INC., Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient(s)

Menthol 1.00%

PURPOSE

External Analgesic

Use(s):

For the temporary relief of pain.

Warning(s):

For external use only.

Do not use

on damaged or broken skin. Avoid contact with the eyes. Do not bandage tightly.

Stop use if 

rash or irritation develops and lasts. 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.

If pregnant or breast-feeding,

ask a health professional before use.

Direction(s):

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Other information:

Protect the product in this container from excessive heat and direct sun.

Other Ingredients:

Aleurites Moluccanus Seed Oil, Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Ethylhexyl Palmitate, Ethylhexylglycerin, Glycerin, Hedera Helix (lvy) Extract, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Polysorbate 60, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopherol, Triethanolamine, Water (Aqua).

Questions?

info@phizico.com

Package Labeling:

INGREDIENTS AND APPEARANCE

PHIZICO PAIN RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85832-621
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HEDERA HELIX TOP (UNII: ZP9XFG71A7)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALMOND OIL (UNII: 66YXD4DKO9)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85832-621-00	1 in 1 BOX	05/31/2025
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/31/2025

Labeler - ER3 BRANDS INC. (132308127)

Registrant - Pure Source, LLC (080354456)