61010-5800,safetec First Aid 1% Hydrocortisone Cream

61010-5800,safetec First Aid 1% Hydrocortisone Cream
SPL v5
SPL
SPL Set ID da2b3b2c-11e0-401b-bbd2-d019271d1b3d
Route
TOPICAL
Published
Effective Date 2020-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Alcohol Methylparaben Mineral Oil Paraffin Petrolatum Propylparaben Water Cetostearyl Alcohol Polysorbate 60 Peg-150 Distearate Steareth-20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-12-15

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

Uses:
  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor
Section 42229-5

Drug Facts

Section 50570-1
  • Do not usefor the treatment of diaper rash
  • in eyes
  • for feminine itching
  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with any other Hydrocortisone product unless you have consulted a doctor
Warnings:
  • For external use only
Directions:
  • for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and 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
  • children under 12 years of age: for external anal itching, consult a doctor
Active Ingredient

Hydrocortisone 1.0%

Other Information:
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets
Inactive Ingredients:

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

Principal Display Panel

PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label

Safetec

1% Hydrocortisone Cream™

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Keep Out of Reach of Children.

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

Principal Display Panel – Box Label

NDC 61010-5800-2

Safetec

First Aid

1% Hydrocortisone Cream

For Temporary Relief of

Itching Associated with

Minor Skin Irritations,

Inflammation, or Rashes

Reorder no. 53110

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Questions Or Comments? 1 800 456 7077

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 . 800-456-7077

www.safetec.com

Principal Display Panel – 10 Packet Box Label

Safetec ®

FIRST AID

Hydrocortisone Cream

1% Hydrocortisone for relief from itching,

inflammation, and rashes

10 Packets

Each Packet Net Wt. 0.9g

Made in USA

Reorder no. 53108


Structured Label Content

Uses:
  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor
Section 42229-5 (42229-5)

Drug Facts

Section 50570-1 (50570-1)
  • Do not usefor the treatment of diaper rash
  • in eyes
  • for feminine itching
  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with any other Hydrocortisone product unless you have consulted a doctor
Purpose

Anti-itch

Warnings:
  • For external use only
Directions:
  • for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and 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
  • children under 12 years of age: for external anal itching, consult a doctor
Active Ingredient (Active ingredient)

Hydrocortisone 1.0%

Other Information: (Other information:)
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets
Inactive Ingredients: (Inactive ingredients:)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label

Safetec

1% Hydrocortisone Cream™

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

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

Principal Display Panel – Box Label (PRINCIPAL DISPLAY PANEL – Box Label)

NDC 61010-5800-2

Safetec

First Aid

1% Hydrocortisone Cream

For Temporary Relief of

Itching Associated with

Minor Skin Irritations,

Inflammation, or Rashes

Reorder no. 53110

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Questions Or Comments? 1 800 456 7077 (Questions or Comments? 1-800-456-7077)

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 . 800-456-7077

www.safetec.com

Principal Display Panel – 10 Packet Box Label (PRINCIPAL DISPLAY PANEL – 10 Packet Box Label)

Safetec ®

FIRST AID

Hydrocortisone Cream

1% Hydrocortisone for relief from itching,

inflammation, and rashes

10 Packets

Each Packet Net Wt. 0.9g

Made in USA

Reorder no. 53108


Advanced Ingredient Data


Raw Label Data

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