Quality Health (as PLD) - Paingone - Freeze (80223-002) - DELIST

Paingone Freeze 5 by

Drug Labeling and Warnings

Paingone Freeze 5 by is a Otc medication manufactured, distributed, or labeled by QUALITY HEALTH INNOVATIONS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAINGONE FREEZE 5- menthol gel 
QUALITY HEALTH INNOVATIONS LIMITED

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Quality Health (as PLD) - Paingone - Freeze (80223-002) - DELIST

Active Ingredient

Menthol   5%

Purpose

Cooling pain relief

Uses

Temporary pain relief associated with sprains, strains, backache, arthritis, aching muscles and joints.

Warnings

For external use only.

Flammable: Keep away from open flame or excessive heat.

Ask a doctor before useif you are: pregnant or breastfeeding, suffering from a skin condition.


When using this product: Avoid contact with the eyes or mucous membranes. Do not apply to wounds or inflamed or broken skin. Cease use if a rash or irritation occurs. Do not use with other topical treatments. Do not use under bandages or occlusive dressings


Stop use and ask a doctor if: Condition worsens, Symptoms persist for more than 7 days, Symptoms clear up and recur within a few days


Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center immediately

Directions

Adults and children 2 years and older: Apply a small amount to the affected area and massage gently, no more than 4 times per day. Wash hands with cool water after use. Children under 2 years of age: Consult a doctor.

Inactive Ingredient

Water, Aloe Barbadensis Leaf Juice, SD Alcohol 40B, Arnica Montana (Arnica) Flower Extract, Propylene Glycol, Acrylates/C10-30 alkyl Acrylate Crosspolymer, Pyridoxine HCL Crystalline (B6), Methylsulfonylmethane (MSM), Aminomethyl, Propanol, FD&C Blue #1

Product label

image description

PAINGONE FREEZE 5 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80223-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80223-002-01177 mL in 1 TUBE; Type 0: Not a Combination Product06/01/202212/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/01/202212/31/2023
Labeler - QUALITY HEALTH INNOVATIONS LIMITED (985757940)

Revised: 3/2024
Document Id: 14ac2b43-6b49-5532-e063-6294a90a69d4
Set id: 0b1ff981-bf22-4d12-8484-c5fa3b1a4000
Version: 4
Effective Time: 20240327