HYDROCORTISONE  - hydrocortisone acetate ointment 
Water-Jel Technologies

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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1% Hydrocortisone Cream

Active ingredient

Hydrocortisone acetate (equivalent to  Hydrocortisone 1%)

Purpose

Anti-itch cream

Uses

Warnings

For external use only

Do not use

for the treatment of diaper rash. Consult a doctor

When using this product

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you've consulted a doctor

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist more than 7 days
  • condition clears up and occurs again within a few days

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions ?

800-275-3433

info@waterjel.com

www.waterjel.com

Principal Display Panel

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HYDROCORTISONE  
anti-itch cream ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59898-800
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59898-800-03 25 in 1 BOX, UNIT-DOSE
1 0.9 g in 1 PACKET
2 NDC:59898-800-02 144 in 1 BOX, UNIT-DOSE
2 0.9 g in 1 PACKET
3 NDC:59898-800-01 1728 in 1 CARTON
3 0.9 g in 1 PACKET
4 NDC:59898-800-36 0.9 g in 1 PACKET
5 NDC:59898-800-32 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/30/2010
Labeler - Water-Jel Technologies (155522589)
Establishment
Name Address ID/FEI Business Operations
Water-Jel Technologies 155522589 manufacture(59898-800)

Revised: 3/2013
Document Id: 44191dd1-6b56-456d-b503-3e996e0a2d5f
Set id: 3d34ae31-265a-46bc-a52d-546ea5bb24b6
Version: 2
Effective Time: 20130322
 
Water-Jel Technologies