Label: NATUREPLEX HYDROCORTISONE HYDRO- hydrocortisone cream
- NDC Code(s): 67234-010-01
- Packager: Natureplex, LLC
- 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 November 30, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Avoid contact with eyes.
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
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Directions
For itching associated with minor skin irritations, 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: Consult a doctor
For external anal and genital itching:
Adults and children 12 years of age and older:
- when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- apply to affected area not more than 3 to 4 times daily
Children under 12 years of age: Consult a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
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INGREDIENTS AND APPEARANCE
NATUREPLEX HYDROCORTISONE HYDRO
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-010-01 28 g in 1 TUBE; Type 0: Not a Combination Product 01/22/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/22/2008 Labeler - Natureplex, LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex, LLC 062808196 manufacture(67234-010)
