PANTIN by tmt america llc / TMT America LLC

PANTIN by

Drug Labeling and Warnings

PANTIN by is a Otc medication manufactured, distributed, or labeled by tmt america llc, TMT America LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PANTIN- lidocain cream 5% cream 
tmt america llc
Reference Label Set Id: c4405031-1e35-2a52-e053-2a95a90aa7b3

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

PANTIN 
lidocain cream 5% cream

Product 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)

Revised: 6/2021

Document Id: c481f64d-4f84-1554-e053-2a95a90a2f90

34390-5

Set id: c481ebf1-1972-1e1c-e053-2995a90a78b4

Version: 3

Effective Time: 20210611