PANTIN- lidocain cream 5% cream 
tmt america llc
Reference Label Set Id: c481ebf1-1972-1e1c-e053-2995a90a78b4

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.

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ACTIVE INGREDIENTS:

Lidocaine BP 5%w/w

PURPOSE:

Topical Anaesthetic

INDICATIONS & USAGE

Uses for temporary relief of pain and itching due to minor skin irritation . To provide topical local analgesia for superficial

dermatological procedures.

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

Keep out of reach of children.​ If product is swallowed, get medical help or contact a Poison Control Center right away.

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:

Cetostearyl Alcohol , Ceto Macrogol 1000 , Micro Wax, Paraffin Wax, Light Liquid Paraffin, Propylene Glycol, Glycerin & Methyl Paraben

OTHER INFROMATIONS:

Protect this product from excessive heat and direct Sun - Please test on small area before use.

* These statements are not evaluated by Food & Drug Administration.

PRINCIPAL DISPLAY PANEL

MAX STREGTH FAST ACTING  PANTIN  Topical Aneasthetic cream  Tattooing- body piercing-Laser treatment-Body waxing  www.pantincream.com  50gNDC 81959-0001-3 MAX STREGTH FAST ACTING  PANTIN  Lidocaine 5%  Topical Aneasthetic cream  Tattooing- body piercing-Laser treatment-Body waxing  30gNDC 81959-0001-3 MAX STREGTH FAST ACTING  PANTIN  Lidocaine 5%  Topical Aneasthetic cream  Tattooing- body piercing-Laser treatment-Body waxing  30gNDC 81959-0001-1  MAX STREGTH FAST ACTING  PANTIN  Topical Aneasthetic cream  Tattooing- body piercing-Laser treatment-Body waxing  www.pantincream.com100g

PANTIN 
lidocain cream 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81959-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81959-0001-51 in 1 CARTON05/21/2019
150 g in 1 JAR; Type 0: Not a Combination Product
2NDC:81959-0001-11 in 1 CARTON05/21/2019
2100 g in 1 JAR; Type 0: Not a Combination Product
3NDC:81959-0001-31 in 1 CARTON06/15/2021
330 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/21/2019
Labeler - tmt america llc (042585222)
Registrant - TMT America LLC (042585222)

Revised: 10/2021
Document Id: cdabe6d8-5cb0-1fc7-e053-2a95a90a32e1
Set id: cdae75e3-4d35-7a62-e053-2995a90a7842
Version: 4
Effective Time: 20211006
 
tmt america llc