HYDROCORTISONE WITH ALOE- hydrocortisone with aloe anti itch cream 
NeilMed Pharmaceuticals Inc.

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NeilMed Hydrocortisone 1% Cream with Aloe Anti-Itch

Drug Facts

Active Ingredients Hydrocortisone, USP 1%

Purpose

Anti-itch

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:

For external use only Do not use ■ for external feminine itching if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

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

■ symptoms last for more than 7 days. ■ the condition gets worse ■ symptoms clear up and occur again in a few days ■ rectal bleeding occurs, consult doctor promptly.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

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

Other information:

■ Storage temperature: not to exceed 30°C (86°F). Protect from freezing.
■ Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients:

Aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alchol, cetyl palmitate, glyceryl, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH.

TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Hydrocream 1%

1oz

HYDROCORTISONE WITH ALOE 
hydrocortisone with aloe anti itch cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-317
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
PEG-40 MONOSTEARATE (UNII: ECU18C66Q7)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-317-011 in 1 CARTON08/18/2023
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:13709-317-021 in 1 CARTON08/18/2023
256 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01508/18/2023
Labeler - NeilMed Pharmaceuticals Inc. (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals Inc.799295915manufacture(13709-317)

Revised: 6/2024
Document Id: 1bc78db9-458f-b456-e063-6394a90aa987
Set id: 032b9f58-5f64-04dd-e063-6294a90a6bb9
Version: 3
Effective Time: 20240626
 
NeilMed Pharmaceuticals Inc.