Daily Defense Skin Protectant Cream, Single (81310-005-03) Daily Defense Skin Protectant Cream, 3 pack (81310-005-33)

Medcosa Daily Defense Skin Protectant by

Drug Labeling and Warnings

Medcosa Daily Defense Skin Protectant by is a Otc medication manufactured, distributed, or labeled by STRETTON ONLINE LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDCOSA DAILY DEFENSE SKIN PROTECTANT- zinc oxide cream 
STRETTON ONLINE LTD.

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Daily Defense Skin Protectant Cream, Single (81310-005-03)
Daily Defense Skin Protectant Cream, 3 pack (81310-005-33)

Drug Facts
Active Ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

• Offers temporary, quick and effective relief for minor skin irritation due to diaper rash
• Minor skin irritations
• Reliable protection from dampness
• Helps prevent, helps relieve, and temporarily protects chafed, chapped, or cracked skin

Warnings

Store at controlled room temperature.

When using this product

do not get into eyes.

Stop use and ask a doctor if

condition worsens or if symptoms last more than 7 days or clear up and occur again within a few days.

Do not use

if safety seal under cap is broken or missing

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

• Cleanse area, pat dry, then apply a thin layer of cream.
• Apply the cream to the afefcted area as needed.

Inactive Ingredients

Alanine, Aloe Barbadensis Leaf Extract, Arginine, Aspartic Acid, Beeswax, Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cyclopentasiloxane, Dimethicone, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, Glycerin, Glycine, Histidine, Magnesium Alumunium Silicate, Mineral Oil, Olea Europaea (Olive) Fruit Extract, Panthenol, Phenoxyethanol, Polysorbate 60, Potassium Cetyl Phosphate, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Serine, Tocopheryl Acetate, Valine, Water, Xanthan Gum

Other Information

Keep in a cool dry environment. Use within 12 months of opening.

Medcosa Daily Defense Skin Protectant Cream

Daily defense cream with dimethicone and zinc oxide.

Protect. Soothe. Nourish

Plant Based Ingredients

Cleans off easily

3.5 oz (81310-005-03)

MEDCOSA DAILY DEFENSE SKIN PROTECTANT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81310-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCINE (UNII: TE7660XO1C)
HISTIDINE (UNII: 4QD397987E)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VALINE (UNII: HG18B9YRS7)
ALANINE (UNII: OF5P57N2ZX)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
PANTHENOL (UNII: WV9CM0O67Z)
MINERAL OIL (UNII: T5L8T28FGP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALMOND OIL (UNII: 66YXD4DKO9)
ARGININE (UNII: 94ZLA3W45F)
ASPARTIC ACID (UNII: 30KYC7MIAI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CHAMOMILE (UNII: FGL3685T2X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
SERINE (UNII: 452VLY9402)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81310-005-03	1 in 1 BOX	12/03/2021
1		99 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 81310-005-33	3 in 1 PACKAGE	12/03/2021
2		1 in 1 BOX
2		99 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/03/2021	12/21/2023

Labeler - STRETTON ONLINE LTD. (220633327)

Revised: 12/2023

Document Id: 0d0b9493-0c23-220a-e063-6294a90ab139

34390-5

Set id: d241dc52-9415-dbf7-e053-2a95a90ae7bc

Version: 4

Effective Time: 20231221