Hydrocortisone: Package Insert and Label Information

HYDROCORTISONE- hydrocortisone cream
Acme United Corp

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 Facts

Active Ingredients

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations, inflammation or rashes.

Other uses of product should be only under the advice of supervision of a doctor.

Warnings

For external use only

Do not use

  • in eyes
  • for treatment of dipper rash

Stop use, ask a doctor

  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with use of other hydrocortisone products

Keep out of reach of children.

If ingested, contact a Poison Control Center right away

Directions

  • apply to affected area not more than 3 to 5 times daily
  • children under 2: as a doctor

Inactive Ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Principal Display Panel — 0.9g Carton Label

18-012 MISC

FIRST AID ONLY®

Hydrocortisone
Anti-Itch Cream
12 (0.9g) Packets

Ungüento con hidrocortisona para aliviar la comezón
12 sobres de (0.9g)

Principal Display Panel -- 0.9g Carton Label
(click image for full-size original)

Principal Display Panel — 0.9g Packet Label

Anti-Itch Cream

0.9g (1 /32 oz)

FIRST AID ONLY®

www.FirstAidOnly.com

Fairfield, CT 06824

1.800.835.2263

©2015 Acme United Corporation. 810002-revA

Principal Display Panel -- 0.9g Packet Label
(click image for full-size original)
HYDROCORTISONE
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-1132
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone (Hydrocortisone) Hydrocortisone 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
alcohol
methylparaben
mineral oil
paraffin
petrolatum
propylparaben
water
white wax
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0924-1132-02 12 PACKET in 1 CARTON contains a PACKET (0924-1132-01)
1 NDC:0924-1132-01 0.9 g in 1 PACKET This package is contained within the CARTON (0924-1132-02)
2 NDC:0924-1132-03 144 PACKET in 1 CARTON contains a PACKET (0924-1132-01)
2 NDC:0924-1132-01 0.9 g in 1 PACKET This package is contained within the CARTON (0924-1132-03)
3 NDC:0924-1132-04 25 PACKET in 1 CARTON contains a PACKET (0924-1132-01)
3 NDC:0924-1132-01 0.9 g in 1 PACKET This package is contained within the CARTON (0924-1132-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/06/2015
Labeler — Acme United Corp (001180207)
Registrant — Safetec of America, Inc. (874965262)
Establishment
Name Address ID/FEI Operations
Safetec of America, Inc. 874965262 MANUFACTURE (0924-1132)

Revised: 03/2016 Acme United Corp

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