HYDROCORTISONE- cool relief gel with aloe gel 
NeilMed Pharmaceuticals Inc

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.

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Drug Facts

Active Ingredients

Hydrocortisone 1%

Drug Facts

Purpose : Anti-itch

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

Warnings: For external use only

Do not use

Do not use

■ in the genital area if you have a vaginal discharge. Consult a doctor.

■ for the treatment of diaper rash. Consult a doctor.

When using this product

When using this product

■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

Stop use and ask a doctor if ■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor. ■ rectal bleeding occurs

Keep out of reach of children

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

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:

Aloe extract, ascorbic acid, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, chamomile extract, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, PEG-40 stearate, petrolatum, purified water, sd 40 alcohol, vitamin A, vitamin D and vitamin E

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

Cool relief gel

HYDROCORTISONE 
cool relief gel with aloe gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-318
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-318-011 in 1 CARTON08/21/2023
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/21/2023
Labeler - NeilMed Pharmaceuticals Inc (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals Inc799295915manufacture(13709-318)

Revised: 8/2023
Document Id: 032fedc7-16d4-aa9c-e063-6294a90aa445
Set id: 032fedc7-16d3-aa9c-e063-6294a90aa445
Version: 1
Effective Time: 20230821
 
NeilMed Pharmaceuticals Inc