M-61 Biobarrier Renewal Cream

M-61 Biobarrier Renewal Cream
SPL v2
SPL
SPL Set ID 1ee15f84-0561-3cd2-e063-6394a90ab68e
Route
TOPICAL
Published
Effective Date 2024-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (7.5 mg)
Inactive Ingredients
Alkyl (c12-15) Benzoate Hydrogenated Didecene Coco-caprylate/caprate Evening Primrose Oil Toxicodendron Vernicifluum Fruit Rind Wax Cetearyl Olivate Sodium Benzoate Glyceryl Stearate Se Sodium Hydroxide Phytosphingosine Ceramide Np Cholesterol Carbomer Homopolymer, Unspecified Type Sodium Lauroyl Lactylate Ethylhexylglycerin Sorbitan Olivate Sodium Gluconate Water Cetostearyl Alcohol Squalane Ceramide Ap Saccharomyces Cerevisiae Cetearyl Glucoside Ceramide 1 Potassium Sorbate Sodium Stearoyl Glutamate Xanthan Gum Phenoxyethanol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-22
Description

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

Purpose

Purpose Skin Protectant

Medication Information

Indications and Usage

Uses

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

Purpose

Skin Protectant

Description

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

Section 42229-5

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

Section 51945-4

Warnings

Warnings

For external use only.

When using this product do not get into eyes.

Directions

Directions

  • Apply as needed
Do Not Use On

Do not use on

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

Active Ingredient

Allantoin 0.75%

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

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.
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.

Structured Label Content

Indications and Usage (34067-9)

Uses

  • Temporarily protects minor cuts, scrapes, burns
    • Helps prevent and temporarily protects and helps relieve chaged, chapped, or cracked skin
Section 42229-5 (42229-5)

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

Section 51945-4 (51945-4)

Purpose

Purpose

Skin Protectant

Warnings (WARNINGS)

Warnings

For external use only.

When using this product do not get into eyes.

Directions

Directions

  • Apply as needed
Do Not Use On (Do not use on)

Do not use on

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

Active Ingredient

Allantoin 0.75%

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?)

Questions or comments?

800-294-7700 9-5pm EST, Monday-Friday

Stop Use and Ask A Doctor If (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.
Keep Out of Reach of Children (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:34.655680 · Updated: 2026-03-14T23:03:44.598062