BALMEX MULTI-PURPOSE- petrolatum ointment

BALMEX MULTI-PURPOSE by

Drug Labeling and Warnings

BALMEX MULTI-PURPOSE by is a Otc medication manufactured, distributed, or labeled by Randob Labs,Ltd., KIK HOLDCO COMPANY INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredients: Purpose
• Petrolatum 51.1%: Skin protectant

Uses

• temporarily protects minor
  • cuts
  • scrapes
  • burns
• temporarily protects and helps relieve chapped or cracked skin
• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness 

Warnings

For external use only

When using this product

• do not get into eyes.

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• apply as needed
• change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry
• apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other information

• do not use if quality seal is broken
• see bottom of tube for lot number and expiration date

STORAGE AND HANDLING

Inactive ingredients

acacia farnesiana flower extract, allantoin, aloe barbadenis leaf extract, chamomilla recutita (matricaria) flower extract, cholecalciferol, cyclomethicone, dimethicone, fragrance, isopropyl myristate, isopropyl palmitate, lavandula angustifolia (lavender) extract, mineral oil, polyethylene, retinyl palmitate, rosmarinus officinalis (rosemary) extract, silica, tocopheryl acetate, zea mays (corn) oil (245-276)

Questions?

1-833-389-9450

SPL UNCLASSIFIED SECTION

Distributed by RANDOB LABS LTD.
Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 99 g Tube Label

NEW LOOK-SAME PRODUCT

Balmex®
MULTI-PURPOSE

HEALING OINTMENT
Skin Protectant-Petrolatum 51.1%

From diaper rash to
chapped, chafed skin

• ✔ Heals, protects & soothes
• ✔ 7 healing moisturizers
  plus Vitamin A & Vitamin D
• ✔ Clear and easy to apply

Pediatrician Recommended

NET WT
3.5 OZ
(99 g)

INGREDIENTS AND APPEARANCE

BALMEX MULTI-PURPOSE 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52412-450
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	511 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Vachellia Farnesiana Flower (UNII: 8487B3MG6D)
Allantoin (UNII: 344S277G0Z)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Chamomile (UNII: FGL3685T2X)
Cholecalciferol (UNII: 1C6V77QF41)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Cyclomethicone 6 (UNII: XHK3U310BA)
Dimethicone 200 (UNII: RGS4T2AS00)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
Lavandula Angustifolia Subsp. Angustifolia Flowering Top (UNII: 9YT4B71U8P)
Mineral Oil (UNII: T5L8T28FGP)
High Density Polyethylene (UNII: UG00KM4WR7)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Rosemary (UNII: IJ67X351P9)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
.alpha.-tocopherol Acetate, Dl- (UNII: WR1WPI7EW8)
Corn Oil (UNII: 8470G57WFM)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52412-450-35	99 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/27/2015

Labeler - Randob Labs,Ltd. (061995007)

Establishment
Name	Address	ID/FEI	Business Operations
KIK HOLDCO COMPANY INC.		243547333	MANUFACTURE(52412-450)