Label: GENTLE STEPS VITAMINS A AND D DIAPER RASH AND SKIN PROTECTANT- lanolin, petrolatum ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 55910-805-72 - Packager: Old East Main CO.
- 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 October 26, 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?
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SPL UNCLASSIFIED SECTION
Compare to active ingredients of A+D® Original Ointment*
• Helps treat and prevent diaper rash
• Helps seal out wetness
• Dye free, Paraben free & Phthalate free
*This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of A+D® Original Ointment.
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
MADE IN INDIA100% Satisfaction Guaranteed!
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(888) 309-9030
- Packaging
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INGREDIENTS AND APPEARANCE
GENTLE STEPS VITAMINS A AND D DIAPER RASH AND SKIN PROTECTANT
lanolin, petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-805 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:55910-805-72 1 in 1 BOX 10/06/2021 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 10/06/2021 Labeler - Old East Main CO. (068331990) Registrant - Ashtel Studios Inc. (148689180)