MAMA BEAR DIAPER RASH SKIN PROTECTANT- lanolin and petrolatum ointment

mama bear DIAPER RASH by

Drug Labeling and Warnings

mama bear DIAPER RASH by is a Otc medication manufactured, distributed, or labeled by AMAZON.COM SERVICES LLC, Garcoa, Inc., Sigan America, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient	Purpose
Lanolin 15.5%	Skin Protectant
Petrolatum 53.4%	Skin Protectant

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness
• temporarily protects minor.
• cuts
• scrapes
• burns.
• temporarily protects and helps relieve chapped or cracked skin and lips.
• helps protect from the drying effects of wind and cold weather.

Warnings

For external use only

Do not use on

• deep or puncture wounds
• animal bites
• serious burns.

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

• For skin protectant use: Apply as needed
• For diaper rash use: Change wet and soiled diapers promptly. Cleanse the diaper area, and allow to dry. Apply ointment liberally as often a as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

store at room temperature

Inactive ingredients

cod liver oil, fragrance, lecithin, microcrystalline wax, mineral oil, paraffin.

QUESTIONS

Questions or comments? 1-866-567-8600

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: AMAZON.COM SERVICES LLC
SEATTLE, WA 98109

PRINCIPAL DISPLAY PANEL - 454 g Jar Label

mama bear

Compare
to the active
ingredients in
A+D® Original
Ointment

DIAPER RASH
OINTMENT
and All-purpose Skin Protectant

• Helps treat and prevent diaper rash
• Temporarily protects and helps
  relieve minor skin irritation

NET WT 1 LB (454 g)

• Formulated with cod liver oil
  (contains vitamin A and
  vitamin D)
• Helps prevent and temporarily
  protect chafed skin

INGREDIENTS AND APPEARANCE

MAMA BEAR DIAPER RASH   SKIN PROTECTANT
lanolin and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-342
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H)	Lanolin	155 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	534 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Cod Liver Oil (UNII: BBL281NWFG)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
Microcrystalline Wax (UNII: XOF597Q3KY)
Mineral Oil (UNII: T5L8T28FGP)
Paraffin (UNII: I9O0E3H2ZE)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-342-01	454 g in 1 JAR; Type 0: Not a Combination Product	02/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/14/2024

Labeler - AMAZON.COM SERVICES LLC (128990418)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan America, LLC		964976968	MANUFACTURE(72288-342)