OTC Medication Information: HydrocortisoneLotion

HYDROCORTISONELOTION- hydrocortisone ointment
Dr. Dan’s LLC

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.

Hydrocortisone 1.0%‚Äč

Inactive Ingredients: Beeswax, petroleum jelly, mineral oil.

Keep out of reach of children.

Lotion
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HYDROCORTISONELOTION
hydrocortisone lotion ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67516-0109
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PETROLATUM
YELLOW WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67516-0109-1 70.87 g in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/10/2001
Labeler — Dr. Dan’s LLC (080637276)
Registrant — Dr. Dan’s LLC (080637276)

Revised: 10/2019 Dr. Dan’s LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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