GLADSKIN ECZEMA- colloidal oatmeal cream

Glad Skin by

Drug Labeling and Warnings

Glad Skin by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Prime Enterprise. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GLAD SKIN ECZEMA CREAM- colloidal oatmeal lotion 
Prime Enterprises

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.

----------

GLADSKIN ECZEMA- colloidal oatmeal cream

Active Ingredient

Colloidal Oatmeal 0.02%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin iritation and itching due to eczema.

Warnings

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if:

• ​Conditions worsen
• Symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions:

• Apply twice daily, or more as desired, on skin free of other products.
• Let the cream absorb into skin for 5 minutes before applying other products.

Directions

• Apply twice daily, or more as desired, on skin free of other products.
• Let the cream absorb into skin for 5 minutes before applying other products.

Inactive Ingredients

Water, Glycerin, Petrolatum, Mineral Oil, Cetearyl Alcohol, Ceteareth-20, Arginine HCl, Sodium Chloride, Trometamol, Calcium Chloride, sr-(Methionyl Staphylococcus Simulans Polypeptide-1 Dipeptide-53 Staphylococcus Phage 2638A Polypeptide-1)​*

Questions

hello@gladskin.com

GLAD SKIN  ECZEMA CREAM
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0549
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.175 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
TROMETHAMINE (UNII: 023C2WHX2V)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0549-3	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/16/2020

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprise		101946028	pack(58443-0549) , manufacture(58443-0549) , analysis(58443-0549) , label(58443-0549)

Revised: 4/2022

Document Id: dd2d1459-14b1-3b0a-e053-2a95a90a306b

34390-5

Set id: d22f9706-26b4-d4db-e053-2a95a90afb93

Version: 5

Effective Time: 20220421