Label: ICE QUAKE ROLL ON (menthol camphor- natural gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69822-102-03 - Packager: Southern Sales & Service, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 5, 2017
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN
- WARNINGS
- Stop Use
- Uses
- DOSAGE & ADMINISTRATION
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- Ice Quake Roll On
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INGREDIENTS AND APPEARANCE
ICE QUAKE ROLL ON
menthol camphor (natural) gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69822-102 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:69822-102-03 89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 01/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 11/01/2016 Labeler - Southern Sales & Service, Inc. (013114906) Establishment Name Address ID/FEI Business Operations Southern Sales & Service, Inc. 013114906 LABEL(69822-102) Establishment Name Address ID/FEI Business Operations GADAL Laboratories, Inc 841305639 MANUFACTURE(69822-102)