SMART CARE BABY DIAPER RASH AND SKIN PROTECTANT- lanolin, petrolatum ointment

Smart Care Baby Diaper Rash and Skin Protectant by

Drug Labeling and Warnings

Smart Care Baby Diaper Rash and Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Ashtel Studios, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Drug Facts

​Active ingredients

Lanolin 15.5%

Petrolatum 53.4%

​Purpose

Diaper rash ointment

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

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 right away.

​Directions

​for diaper rash use:
  change wet and 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 anytime when exposure to wet diapers may be prolonged
 ​for skin protectant use: ​apply as needed

​Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

​Questions? +1-877-274-8358

You may report serious side effects to this phone number. Mon - Fri 8:00 AM - 5:00 PM PST

SPL UNCLASSIFIED SECTION

WITH VITAMIN A & D

Helps treat & prevent diaper rash with this soothing ointment and skin protectant, which forms a protective barrier that seals out wetness.

Dye Free

Paraben Free

Phthalates Free

Smart Care®

WWW.SMARTCAREUS.COM

​QUESTIONS OR COMMENTS?
1-877-274-8358 TOLL FREE IN U.S.A
1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761

DESIGNED IN U.S.A

MADE IN INDIA

Packaging

INGREDIENTS AND APPEARANCE

SMART CARE BABY DIAPER RASH AND SKIN PROTECTANT 
lanolin, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	15.5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	53.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COD LIVER OIL (UNII: BBL281NWFG)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-073-01	1 in 1 BOX	08/26/2021
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/26/2021

Labeler - Ashtel Studios, Inc (148689180)