Label: HYDROCORTISONE- cool relief gel with aloe gel
- NDC Code(s): 13709-318-01
- 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 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Drug Facts
-
Drug Facts
Uses:
■ temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak and sumac ■insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should oonly be under the advise and supervison of a doctor
- Warnings: For external use only
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
-
Directions
Directions ■ for itching of skin irritation, inflammation, and rashes: ■ 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: ask a doctor ■ If pregnant or breast-feeding: ask a health professional before use. ■ for external anal and genital itching, adults: ■ when practical, clean the affected area with mild soap and warm water and rinse thoroughly ■ gently dry by patting or blotting with toilet tissue or a soft cloth before applying ■ apply to affected area not more than 3 to 4 times daily ■ children under 12 years of age: ask a doctor
- Inactive ingredients:
- SAFE HANDLING WARNING
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
cool relief gel with aloe gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13709-318 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) BENZYL ALCOHOL (UNII: LKG8494WBH) CETYL PALMITATE (UNII: 5ZA2S6B08X) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEG-40 MONOSTEARATE (UNII: ECU18C66Q7) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) VITAMIN D (UNII: 9VU1KI44GP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHAMOMILE (UNII: FGL3685T2X) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) VITAMIN A (UNII: 81G40H8B0T) ALCOHOL (UNII: 3K9958V90M) TOCOPHEROL (UNII: R0ZB2556P8) ALOE (UNII: V5VD430YW9) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13709-318-01 1 in 1 CARTON 08/21/2023 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 08/21/2023 Labeler - NeilMed Pharmaceuticals Inc (799295915) Establishment Name Address ID/FEI Business Operations NeilMed Pharmaceuticals Inc 799295915 manufacture(13709-318)