Label: SMART CARE BABY DIAPER RASH AND SKIN PROTECTANT- lanolin, petrolatum ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 70108-073-01 - Packager: Ashtel Studios, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated August 31, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
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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
- Inactive ingredients
- Questions? +1-877-274-8358
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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 INTERNATIONALPATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE
DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761DESIGNED IN U.S.A
MADE IN INDIA
- Packaging
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INGREDIENTS AND APPEARANCE
SMART CARE BABY DIAPER RASH AND SKIN PROTECTANT
lanolin, petrolatum ointmentProduct 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)
