Label: FREEZE COOLING PAIN RELIEF gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69980-102-01, 69980-102-02, 69980-102-03, 69980-102-04, view more69980-102-05, 69980-102-06, 69980-102-07, 69980-102-08, 69980-102-09, 69980-102-10, 69980-102-11 - Packager: Shandong Vianor Healthy Science Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 25, 2021
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
FREEZE COOLING PAIN RELIEF
freeze cooling pain relief gelProduct 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)