PANTIN- lidocain cream 5% cream

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]

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

INGREDIENTS AND APPEARANCE

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)