TOPCARE  HYDROCORTISONE 1% WITH ALOE- hydrocortisone cream 
Topco Associates 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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TopCare®
Hydrocortisone 1% with Aloe

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch cream

Uses

Warnings

For external use only

Do not use

  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have

  • a vaginal discharge
  • rectal bleeding
  • diaper rash

When using this product consult a doctor before exceeding recommended dosage

Stop use and ask a doctor if

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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

Directions

Adults and children 2 years of age and older:

Children under 2 years of age: do not use. consult a doctor

For external anal itching:

Children under 12 years of age: consult a doctor

Other information

Inactive ingredients

aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, stearyl alcohol

Questions?

Call 1-866-923-4914

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

NDC 36800-059-02

TopCare®
health

MAXIMUM STRENGTH

Hydrocortisone Cream 1%
ANTIPRURITIC (ANTI-ITCH)

with Aloe

NET WT 1 OZ (28.4 g)

•OUR PHARMACISTS•
RECOMMEND

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
TOPCARE   HYDROCORTISONE 1% WITH ALOE
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-059
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
cetostearyl alcohol (UNII: 2DMT128M1S)  
sodium lauryl sulfate (UNII: 368GB5141J)  
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)  
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
glyceryl monostearate (UNII: 230OU9XXE4)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-059-031 in 1 CARTON08/23/1995
160 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:36800-059-021 in 1 CARTON08/23/1995
228.4 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 FINALpart34808/23/1995
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Phamaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Phamaceuticals Inc.206263295MANUFACTURE(36800-059)

Revised: 2/2019
Document Id: 09c7ad10-600d-4f02-874a-d610a9d25009
Set id: 2a235963-4d7a-4f6a-8c02-a0ef4b954585
Version: 2
Effective Time: 20190215
 
Topco Associates LLC