Smart Care Baby Diaper Rash and Skin Protectant: Package Insert and Label Information

SMART CARE BABY DIAPER RASH AND SKIN PROTECTANT- lanolin and petrolatum ointment
Ashtel Studios, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

​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

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANOLIN (LANOLIN) LANOLIN 15.5 g in 100 g
PETROLATUM (PETROLATUM) PETROLATUM 53.4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
COD LIVER OIL
LIGHT MINERAL OIL
MICROCRYSTALLINE WAX
PARAFFIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70108-073-01 1 TUBE in 1 BOX contains a TUBE
1 113 g in 1 TUBE This package is contained within the BOX (70108-073-01)
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)

Revised: 08/2021 Ashtel Studios, Inc

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