Label: ZIHUA EMBROCATION COOLING PAIN RELIEF- camphor menthol methyl salicylate oil
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Contains inactivated NDC Code(s)
NDC Code(s): 49980-003-01, 49980-003-26 - Packager: Hong Kong Zihua Pharmaceutical 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 April 21, 2014
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- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
ZIHUA EMBROCATION COOLING PAIN RELIEF
camphor menthol methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49980-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 11 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g in 100 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) LAVENDER OIL (UNII: ZBP1YXW0H8) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49980-003-01 1 in 1 BOX 1 NDC:49980-003-26 26 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/15/2014 Labeler - Hong Kong Zihua Pharmaceutical Ltd. (663989580) Establishment Name Address ID/FEI Business Operations Hong Kong Zihua Pharmaceutical Ltd. 663989580 manufacture(49980-003)