Label: PANTIN- lidocain cream 5% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81959-0001-1, 81959-0001-3, 81959-0001-5 - Packager: tmt america llc
- 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 October 6, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- PURPOSE:
- INDICATIONS & USAGE
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WARNING:
- For External Use only.
When using this Product - Avoid contact with eyes - Do not use in large quantities, particularly over raw surfaces or blistered areas .
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS FOR USE:
Directions For Adult & Children above 12 years of Age :
· Applied Before the procedure
· Apply very thick to area and around - Once rubbed in
· apply another layer of cream to the area - Cover the area with saran-Wrap in order for it to remain thick.
For Children under 12 years of age: Consult a physician.
- INACTIVE INGREDIENTS:
- OTHER INFROMATIONS:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PANTIN
lidocain cream 5% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81959-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 2.5 g in 50 g Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9O0E3H2ZE) 1.575 g in 50 g METHYLPARABEN (UNII: A2I8C7HI9T) 0.075 g in 50 g WATER (UNII: 059QF0KO0R) 34.025 g in 50 g LIQUID PETROLEUM (UNII: 6ZAE7X688J) 4.65 g in 50 g POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) 0.9 g in 50 g MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 1.275 g in 50 g GLYCERIN (UNII: PDC6A3C0OX) 0.5 g in 50 g CETYL ALCOHOL (UNII: 936JST6JCN) 3.5 g in 50 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 g in 50 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81959-0001-5 1 in 1 CARTON 05/21/2019 1 50 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:81959-0001-1 1 in 1 CARTON 05/21/2019 2 100 g in 1 JAR; Type 0: Not a Combination Product 3 NDC:81959-0001-3 1 in 1 CARTON 06/15/2021 3 30 g in 1 TUBE, WITH APPLICATOR; 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 05/21/2019 Labeler - tmt america llc (042585222) Registrant - TMT America LLC (042585222)
