Label: ROCKSAUCE ICE- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 40104-299-01 - Packager: Ningbo Pulisi Daily Chemical Products Co.,Ltd.
- 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 December 13, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses:
- Warnings:
- Keep out of reach of children.
- Directions:
- When using this product
- Consult a doctor and discontinus use.
- Inactive ingredients:
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ROCKSAUCE ICE
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40104-299 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.006 g in 0.1 g Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40104-299-01 1 in 1 PACKAGE 12/05/2017 1 2.5 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/05/2017 Labeler - Ningbo Pulisi Daily Chemical Products Co.,Ltd. (529047265) Establishment Name Address ID/FEI Business Operations Ningbo Pulisi Daily Chemical Products Co.,Ltd. 529047265 manufacture(40104-299)