NATUREPLEX HYDROCORTISONE HYDRO- hydrocortisone cream 
Natureplex, LLC

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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Hydrocortisone Cream

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Antipruritic (anti-itch)

Uses

Warnings

For external use only.

Avoid contact with eyes.

Do Not Use

  • if you have a vaginal discharge. Consult a doctor.

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

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
  • beeding occurs

If pregnant or breast-feeding, ask a health professional before use.

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

Directions

For itching associated with minor skin irritations, inflammation, and rashes:

Adults and children 2 years of age and older:

Children under 2 years of age: Consult a doctor

For external anal and genital itching:

Adults and children 12 years of age and older:

Children under 12 years of age: Consult a doctor

Other information

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Natureplex™
MAXIMUM STRENGTH

Hydrocortisone Cream

Fast Itch And Rash Relief!

NET WT. 1 Oz. (28g)

Principal Display Panel - 28 g Tube Carton
NATUREPLEX HYDROCORTISONE  HYDRO
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
cetyl alcohol (UNII: 936JST6JCN)  
DMDM Hydantoin (UNII: BYR0546TOW)  
glyceryl monostearate (UNII: 230OU9XXE4)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
polysorbate 20 (UNII: 7T1F30V5YH)  
propylparaben (UNII: Z8IX2SC1OH)  
stearic acid (UNII: 4ELV7Z65AP)  
trolamine (UNII: 9O3K93S3TK)  
edetate trisodium (UNII: 420IP921MB)  
water (UNII: 059QF0KO0R)  
alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-010-0128 g in 1 TUBE; Type 0: Not a Combination Product01/22/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/22/2008
Labeler - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex, LLC062808196manufacture(67234-010)

Revised: 11/2017
Document Id: da2660d2-8e1a-486d-acb1-043266c9473e
Set id: 2fc6a148-34bb-4289-8588-32c1bb011b98
Version: 13
Effective Time: 20171130
 
Natureplex, LLC