Label: FROZEN ICE FAST PAIN RELIEF (menthol camphor- natural gel
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Contains inactivated NDC Code(s)
NDC Code(s): 53113-363-03 - Packager: GADAL Laboratories, Inc
- 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 November 24, 2016
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
For the external use only. Use only as directed.
- If condition worsens, or if symptoms persist for more than 7 days or clear up and occurs again within a few days, discontinue use of this product and consults a doctor.
- Avoid contact with eyes.
- Do not use with other topical products.
- Do not use with heating device.
- Do not apply to open wounds or damaged skin.
In case of accidental ingestion, seek professional help and contact a Poison Control Center immediately.
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PURPOSE
- Other Information:
- FROZEN ICE FAST PAIN RELIEF
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INGREDIENTS AND APPEARANCE
FROZEN ICE FAST PAIN RELIEF
menthol camphor (natural) gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-363 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.5 g in 100 mL CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 0.2 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) ISOPROPYL ALCOHOL (UNII: ND2M416302) TROLAMINE (UNII: 9O3K93S3TK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53113-363-03 89 mL in 1 APPLICATOR; Type 0: Not a Combination Product 11/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/01/2016 Labeler - GADAL Laboratories, Inc (841305639) Establishment Name Address ID/FEI Business Operations GADAL Laboratories, Inc 841305639 MANUFACTURE(53113-363)