Label: HYDROCORTISONE- anti itch ointment
- NDC Code(s): 13709-316-01
- Packager: NeilMed Pharmaceuticals Inc
- 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.
Drug Label Information
Updated August 17, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
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Uses:
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
eczema insect bites poison ivy poison oak poison sumac soaps jewelry detergents cosmetics
psoriasis seborrheic dermatitis for external genital, feminine and anal itching other uses of this product should be only
under the advice and supervision of a doctor - Warnings:
-
Warnings:
When using this product
avoid contact with the eyes
do not begin the use of any other hydrocortisone product unless directed by a doctor
for external anal itching: do not use more than directed unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator.
- Stop use and ask a doctor if :
- Keep out of reach of children.
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Directions
Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily
Children under 2 years of age do not use, consult a doctor
If pregnant or breast-feeding ask a health professional before use.
For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting
with toilet tissue or a soft cloth before application of this product Children under 12 years of age: consult a doctor - STORAGE AND HANDLING
- Other information
- Inactive ingredients
- SAFE HANDLING WARNING
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
anti itch ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13709-316 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 0.0102 g in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13709-316-01 1 in 1 CARTON 08/17/2023 1 28 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 not final part348 08/17/2023 Labeler - NeilMed Pharmaceuticals Inc (799295915) Establishment Name Address ID/FEI Business Operations NeilMed Pharmaceuticals Inc. 799295915 manufacture(13709-316)
