FREEZE COOLING PAIN RELIEF- freeze cooling pain relief gel 
Shandong Vianor Healthy Science Co.,Ltd.

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.

----------

69980-102
FREEZE COOLING PAIN RELIEF

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

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

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

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

69980-102-05 200ml

69980-102-04 150ml69980-102-04 150ml

69980-102-02 50ml

69980-102-02 50ml

69980-102-01 30ml 69980-102-01 30ml

69980-102-03 100ml 69980-102-03 100ml

69980-102-06 30ml

69980-102-06 30ml

69980-102-07 50ml

69980-102-07 50ml

69980-102-08 100ml

69980-102-08 100ml

69980-102-09 150ml

69980-102-09 150ml

69980-102-010 200ml

69980-102-010 200ml

69980-102-011 227ml

69980-102-011 227ml

FREEZE COOLING PAIN RELIEF 
freeze cooling pain relief gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69980-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69980-102-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:69980-102-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:69980-102-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:69980-102-04150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:69980-102-05200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:69980-102-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:69980-102-0750 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
8NDC:69980-102-08100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
9NDC:69980-102-09150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
10NDC:69980-102-10200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
11NDC:69980-102-11227 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/30/2020
Labeler - Shandong Vianor Healthy Science Co.,Ltd. (554532204)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Vianor Healthy Science Co.,Ltd.554532204manufacture(69980-102)

Revised: 1/2021
Document Id: b9c612ef-bd1a-d1e2-e053-2995a90a3af7
Set id: ad967560-7bce-fd6a-e053-2a95a90a7dca
Version: 2
Effective Time: 20210125
 
Shandong Vianor Healthy Science Co.,Ltd.