Label: AMINO RIP MUSCLE PAIN RELIEF- lidocaine hcl liquid
- NDC Code(s): 54859-415-02
- Packager: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated October 13, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Warnings For external use only
Do not use
- on large areas of the body or on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor.
When using this product
Use only as direct. Read and follow all directions and warnings on this label.
- Do not allow contact with eyes
- Do not bandage or apply local heat (such as heating pads) to the area of use.
Stop use and ask doctor if
- Condition worsens
- Symptoms persist for more than 7 days or clear up and occur again within a few days
- If pregnant or breast feeding, ask a doctor before use.
- Keep out of the reach of children
- If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
AMINO RIP MUSCLE PAIN RELIEF
lidocaine hcl liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-415 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 mg in 100 mL Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-415-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 10/01/2019 Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305) Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305) Establishment Name Address ID/FEI Business Operations LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION 037342305 manufacture(54859-415)