Label: SKIN PROTECTANT- colloidal oatmeal ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69123-111-01, 69123-111-02, 69123-111-03 - Packager: ELAJ, LLC
- 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 July 25, 2014
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- Active Ingredient
- Purpose
- Uses
- WARNINGS
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Storage
- Inactive Ingredients
- Questions or Comments
- Product Packaging Labels
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INGREDIENTS AND APPEARANCE
SKIN PROTECTANT
colloidal oatmeal ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69123-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 0.57 g in 57 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) GLYCERIN (UNII: PDC6A3C0OX) HONEY (UNII: Y9H1V576FH) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) YELLOW WAX (UNII: 2ZA36H0S2V) Talc (UNII: 7SEV7J4R1U) BORIC ACID (UNII: R57ZHV85D4) ZINC OXIDE (UNII: SOI2LOH54Z) STEARIC ACID (UNII: 4ELV7Z65AP) Vanilla (UNII: Q74T35078H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69123-111-01 1 in 1 BOX 1 57 g in 1 CONTAINER 2 NDC:69123-111-02 1 in 1 BOX 2 113 g in 1 CONTAINER 3 NDC:69123-111-03 1 in 1 BOX 3 227 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/25/2014 Labeler - ELAJ, LLC (051975632) Registrant - ELAJ, LLC (051975632)