NDC | 53113-362-09 |
Set ID | 7bf21905-975a-472d-a2d6-a9c1408e7f95 |
Category | HUMAN OTC DRUG LABEL |
Packager | GADAL Laboratories, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENTS
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
For the external use only. When using this product use as directed.
- Do not bandage tightly or use with heating pad. Avoid contact with eyes and mucous membranes.
- Do not apply to wounds or damaged, broken, or irritated skin.
- If severe burning sensation occurs, discontinue use immediately.
- Do not expose the area treated with product to heat or direct sunlight.
- Stop use and ask a doctor if conditions worsen, redness is present, irritation develops.
If swallowed, get medical help or contact a Poison Control Center right away. IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.
- DOSAGE & ADMINISTRATION
- PURPOSE
- GADADERM Frozen Ice Advance Pain Relief
-
INGREDIENTS AND APPEARANCE
GADADERM FROZEN ICE ADVANCE PAIN RELIEF
salicylic acid menthol camphor (natural) gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-362 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 10 in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 in 100 g CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 3.1 in 100 g Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53113-362-09 99 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/01/2016 Labeler - GADAL Laboratories, Inc (841305639) Establishment Name Address ID/FEI Business Operations GADAL Laboratories, Inc 841305639 MANUFACTURE(53113-362)