Label: AQUANIL HC- hydrocortisone lotion
- NDC Code(s): 0096-0732-04, 0096-0732-15
- Packager: Person and Covey
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Updated January 21, 2020
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- Active Ingredient
Stop Use and Ask a Doctor
Stop use and ask a doctor if:
-If symptoms persit for more than 7 days or clear up and occur again within a few days. Discocntinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
-Do no use for diaper rash. Consult a doctor.
- Keep out of the Reach of Children
- Inactive Ingredients
- Package Label. Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0096-0732 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0096-0732-04 118 g in 1 BOTTLE; Type 0: Not a Combination Product 01/08/1995 2 NDC:0096-0732-15 16 g in 1 BOTTLE; Type 0: Not a Combination Product 01/08/1995 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/08/1995 Labeler - Person and Covey (008482473) Establishment Name Address ID/FEI Business Operations Person and Covey 008482473 manufacture(0096-0732)