BIOBARRIER RENEWAL CREAM- allantoin cream

BioBarrier Renewal Cream by

Drug Labeling and Warnings

BioBarrier Renewal Cream by is a Otc medication manufactured, distributed, or labeled by bluemercury. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

m-61

powerful skincare

BioBarrier

Renewal

Cream

RENEWING

NUTRIENT-RICH

TRIPLE CERAMIDE

AND ALLANTOIN

CUSHION CREAM

Advanced triple ceramide
renewal treatment
with 0.75% allantoin,
essential fatty acids and
plant-derived squalane

all skin types

100% paraben-free
100% synthetic fragrance-free
dermatologist tested
allergy tested

1.7 Oz. / 50 g

Active Ingredients

Active Ingredient

Allantoin 0.75%

Purpose

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

• Temporarily protects minor cuts, scrapes, burns
  • Helps prevent and temporarily protects and helps relieve chaged, chapped, or cracked skin

WARNINGS

Warnings

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if

Stop use and ask a doctor if

• Conition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

Do not use on

• Deep or puncture wounds
• Animal bites
• Serious burns.

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.

Directions

Directions

• Apply as needed

Inactive Ingredients

Inactive Ingredients

Water, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Hydrogenated Didecene, Coco-Caprylate/Caprate, Glyceryl Stearate SE, Oenothera Biennis (Evening Primrose) Oil, Squalane, Rhus Verniciflua (Varnish Tree) Peel Wax, Cetearyl Olivate, Saccharomyces Ferment Filtrate, Cetearyl Glucoside, Sorbitan Olivate, Ceramide NP, Ceramide AP, Cholesterol, Ceramide EOP, Phytosphingosine, Sodium Hydroxide, Potassium Sorbate, Sodium Benzoate, Sodium Gluconate, Sodium Stearoyl Glutamate, Carbomer, Sodium Lauroyl Lactylate, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin.

Questions or comments?

Questions or comments?
800-294-7700 9-5pm EST, Monday-Friday

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOBARRIER RENEWAL CREAM 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72203-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	7.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HYDROGENATED DIDECENE (UNII: 048B98MT5O)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CERAMIDE NP (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM GLUCONATE (UNII: R6Q3791S76)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SQUALANE (UNII: GW89575KF9)
CERAMIDE AP (UNII: F1X8L2B00J)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CERAMIDE 1 (UNII: 5THT33P7X7)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72203-019-02	1 in 1 BOX	05/22/2024
1	NDC: 72203-019-01	50 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	M016	05/22/2024

Labeler - bluemercury (097435361)