Globe Hydro Gel

Globe Hydro Gel
SPL v2
SPL
SPL Set ID 02e8e5d0-7844-39fe-e063-6394a90a57e1
Route
TOPICAL
Published
Effective Date 2024-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (20 g)
Inactive Ingredients
Aloe Vera Leaf Methylparaben Peg-4 Oleate Propylene Glycol .alpha.-tocopherol Acetate Allantoin Water Sodium Polyacrylate (2500000 Mw) Diazolidinyl Urea Propylparaben Peg-60 Hydrogenated Castor Oil Edetate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-14

Description

Glycerin 20%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Glycerin 20%

Uses
  • Temporarily protects and helps relieve minor skin irritation and itching of minor cuts, scrapes and burns
  • Maintains a moist wound environment
  • Ideal for managment of stasis ulcers, pressure ulcers (stages 1-4), first and second degree burns, cuts, post-operative incisions, and skin conditions associated with peristomal care.
Section 51945-4

Warning

For External Use Only

Do Not Use

Do not use on Deep pumcture wounds or Animal Bites

Directions
  • Apply liberally as often as necessary to cover affected areas.
  • If gauze is used as a wound covering, moisten first.
  • Children under 6 months: Consult a doctor before use
Distributed By

Distributed By

Trifecta Pharmaceuticals USA®

101 NE Third Avenue Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Active Ingredient

Glycerin 20%

Other Information

Store at room temperature 15°-30°C (59°-86°F)

**Tamper evident. Do not use if seal is damaged

Inactive Ingredients

Allantoin, Aloe Vera gel, Diazolidinyl urea, Methylparaben, PEG-4 olivate, PEG-60, hydrogenated castor oil, Propylene glycol, Propylparaben, Purified water, Sodium Polyacrylate, Tetrasodium EDTA, Tocopherol acetate

Questions Or Comments

Call Toll Free 1-888-296-9067

When Using This Product

Avoid contact with eyes

Stop Use and Ask A Doctor

  • condition worsens or does not improve within 10-14 days
Keep Out of the Reach of Children

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


Structured Label Content

Uses
  • Temporarily protects and helps relieve minor skin irritation and itching of minor cuts, scrapes and burns
  • Maintains a moist wound environment
  • Ideal for managment of stasis ulcers, pressure ulcers (stages 1-4), first and second degree burns, cuts, post-operative incisions, and skin conditions associated with peristomal care.
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warning

For External Use Only

Do Not Use (DO NOT USE)

Do not use on Deep pumcture wounds or Animal Bites

Directions
  • Apply liberally as often as necessary to cover affected areas.
  • If gauze is used as a wound covering, moisten first.
  • Children under 6 months: Consult a doctor before use
Distributed By

Distributed By

Trifecta Pharmaceuticals USA®

101 NE Third Avenue Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Active Ingredient

Glycerin 20%

Other Information (Other information)

Store at room temperature 15°-30°C (59°-86°F)

**Tamper evident. Do not use if seal is damaged

Inactive Ingredients

Allantoin, Aloe Vera gel, Diazolidinyl urea, Methylparaben, PEG-4 olivate, PEG-60, hydrogenated castor oil, Propylene glycol, Propylparaben, Purified water, Sodium Polyacrylate, Tetrasodium EDTA, Tocopherol acetate

Questions Or Comments (Questions or Comments)

Call Toll Free 1-888-296-9067

When Using This Product (When Using this product)

Avoid contact with eyes

Stop Use and Ask A Doctor (Stop use and ask a doctor)

  • condition worsens or does not improve within 10-14 days
Keep Out of the Reach of Children (Keep out of the reach of children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)