FREEZE COOLING PAIN RELIEF gel

FREEZE COOLING PAIN RELIEF by

Drug Labeling and Warnings

FREEZE COOLING PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Shandong Vianor Healthy Science Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Menthol 4%

Purpose

/

Use

Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

Warnings

for external use only.
In cose of Ingestion seek medical assistance.
If a rash appears, dis.continue use.

Do not use

If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12

WHEN USING

If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12

STOP USE

Consult your doctor or pharmacist before use if you are diabetic, pregnant or breastfeeding. have poor circulation, a skin condition or if symptoms persists.

KEEP OUT OF REACH OF CHILDREN

Directions

Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

Other information

Inactive ingredients

Water, Alcohol Denat., Polysorbate-20, Glycerin, Propylene Glycol, Triethanolamine, Phenoxyethanol, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer. Cinnamomum Camphora (Camphor) bark oil, Ethylhexylglycerin, limonene, Linalool, Cl42090 (FD&C Blue 1), CL17200 (D&C Red 33).

Package Label - Principal Display Panel

69980-102-05 200ml

69980-102-04 150ml

69980-102-02 50ml

69980-102-01 30ml

69980-102-03 100ml

69980-102-06 30ml

69980-102-07 50ml

69980-102-08 100ml

69980-102-09 150ml

69980-102-010 200ml

69980-102-011 227ml

INGREDIENTS AND APPEARANCE

FREEZE COOLING PAIN RELIEF 
freeze cooling pain relief gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69980-102
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
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CAMPHOR OIL (UNII: 75IZZ8Y727)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TROLAMINE (UNII: 9O3K93S3TK)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69980-102-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 69980-102-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 69980-102-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 69980-102-04	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 69980-102-05	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 69980-102-06	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 69980-102-07	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 69980-102-08	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC: 69980-102-09	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC: 69980-102-10	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
11	NDC: 69980-102-11	227 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/30/2020

Labeler - Shandong Vianor Healthy Science Co.,Ltd. (554532204)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Vianor Healthy Science Co.,Ltd.		554532204	manufacture(69980-102)