Label: LIDOCAINE PAIN RELIEVING CREME- lidocaine hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71301-006-24 - Packager: Yash Pharmaceuticals
- 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 14, 2017
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- Official Label (Printer Friendly)
- Lidocaine Pain Relieving Creme
- Active ingredient
- Purpose
- Uses
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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 directed. Read and follow all directions and warnings on this carton.
- do not allow contact with the eyes
- do not bandage or apply local heat (such as heating pads) to the area of use
- on large areas of the body or on cut, irritated or swollen skin
- Directions
- Inactive ingredients
- Outer Label
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INGREDIENTS AND APPEARANCE
LIDOCAINE PAIN RELIEVING CREME
lidocaine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71301-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-2 (UNII: 7H8VAM7778) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBIC ACID (UNII: X045WJ989B) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71301-006-24 192 in 1 CASE 03/17/2017 1 76.5 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 03/03/2017 Labeler - Yash Pharmaceuticals (871409551) Registrant - VELOCITY PHARMA (962198409) Establishment Name Address ID/FEI Business Operations Yash Pharmaceuticals 871409551 manufacture(71301-006) , label(71301-006)