ELTAMD LASER BALM- petrolatum skin protectant ointment

EltaMD Laser Balm by

Drug Labeling and Warnings

EltaMD Laser Balm by is a Otc medication manufactured, distributed, or labeled by EltaMD, Inc., Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only.  Do not use on damaged or broken skin.  When using this product do not get into eyes.  Stop use and ask a physician if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Active Ingredient

Petrolatum 60%   Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin or lips.

Temporarily protects minor cuts, scrapes and burns.

Directions

Apply as needed or as directd by physician.  For best results, apply liberally to moist skin.

Directions

Apply as needed or as directd by physician.  For best results, apply liberally to moist skin.

Keep out of reach of children

Keep out of Reach of Children

Inactive Ingredients

mircocrystalline wax, paraffin

LASERUC

INGREDIENTS AND APPEARANCE

ELTAMD LASER BALM 
petrolatum skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2277
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	600 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2277-4	108 g in 1 JAR; Type 0: Not a Combination Product	01/10/2018
2	NDC: 72043-2277-5	5 g in 1 PACKET; Type 0: Not a Combination Product	01/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/10/2018

Labeler - EltaMD, Inc. (611921669)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72043-2277)