Paingone Freeze by QUALITY HEALTH INNOVATIONS LIMITED Paingone - Freeze

Paingone Freeze by

Drug Labeling and Warnings

Paingone Freeze 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- menthol gel 
QUALITY HEALTH INNOVATIONS LIMITED

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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Paingone - Freeze

Active Ingredient

Menthol   4%

Purpose

Cooling pain relief

Uses

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

Warnings

For external use only.

Flammable: Keep away from open flame or excessive heat.

Ask a doctor before use if 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, Alcohol Denat., Polysorbate-20,Glycerin, Propylene Glycol, Triethanolamine,Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Cinnamomum Camphora (Camphor)bark oil, Ethylhexylglycerin, Limonene, Linalool, Cl 42090(FD&C Blue 1), CL17200 (D&C Red 33)

Product label

PAINGONE FREEZE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80223-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80223-001-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2020	09/30/2020
2	NDC: 80223-001-02	227 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2020	06/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2020	06/23/2022

Labeler - QUALITY HEALTH INNOVATIONS LIMITED (985757940)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Vianor Healthy Science Co.,Ltd		554532204	manufacture(80223-001)

Revised: 11/2022

Document Id: ed97504f-a6a6-fb1c-e053-2a95a90a5bbd

34390-5

Set id: 612c268f-d728-4755-ae2c-1859f97c130f

Version: 4

Effective Time: 20221116