Label: ROCKSAUCE FIRE- methyl salicylate, menthol and capsaicin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73344-103-01, 73344-103-02 - Packager: NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT 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 September 29, 2019
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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 FIRE
methyl salicylate, menthol and capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73344-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 20 mg in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg in 100 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.2 mg in 100 mL Inactive Ingredients Ingredient Name Strength ARNICA MONTANA (UNII: O80TY208ZW) ETHYLHEXYL PALMITATE (UNII: 2865993309) 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:73344-103-01 1 in 1 PACKAGE 09/29/2019 1 88.7 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:73344-103-02 1 in 1 PACKAGE 09/29/2019 2 355 mL 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 09/29/2019 Labeler - NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD (404080257) Establishment Name Address ID/FEI Business Operations NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD 404080257 manufacture(73344-103)