MedPath

Tagrid Skin Repair Cream

Initial Drug Listing-Tagrid Skin Repair Ointment Allantoin 1%

Approved
Approval ID

34a8bf10-1c18-1c14-e063-6394a90a0a6f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 8, 2025

Manufacturers
FDA

TAGRID LLC

DUNS: 118778969

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Allantoin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85384-0007
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Allantoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 8, 2025
FDA Product Classification

INGREDIENTS (15)

GOSSYPIUM HERBACEUM (COTTON) SEED OILInactive
Code: N5CFT140R8
Classification: IACT
MENTHA PIPERITA (PEPPERMINT) OILInactive
Code: AV092KU4JH
Classification: IACT
SALVIA OFFICINALIS (SAGE) OILInactive
Code: U27K0H1H2O
Classification: IACT
SILVER STEARATEInactive
Code: 4H6PCL92ZN
Classification: IACT
ZINC OXIDEInactive
Code: SOI2LOH54Z
Classification: IACT
ALLANTOINActive
Quantity: 10 mg in 1 g
Code: 344S277G0Z
Classification: ACTIB
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OILInactive
Code: 724GKU717M
Classification: IACT
THUJA OCCIDENTALIS LEAFInactive
Code: 0T0DQN8786
Classification: IACT
COCOS NUCIFERA (COCONUT) OILInactive
Code: Q9L0O73W7L
Classification: IACT
BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILInactive
Code: VIF565UC2G
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

Skin Repair Oinitment

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/25/2025

Temporarily protects minor cuts, scrapes, and burns. Helps relieve and promote healing of chapped, chafed, or cracked skin.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/26/2025

Allantoin 1% (w/w/)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/26/2025

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

For external use only

Do not use: In the eyes, nose, mouth, or on large
areas of the body
If you are allergic to mupirocin or any of the ingredients in this product

Ask a doctor before use if you have:
Deep or puncture wounds
Animal bites

Serious burns
Large areas of damaged skin

■ Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
■ Use only as directed. Do not use for longer than prescribed.
■ Do not bandage tightly unless directed by a doctor.

Stop use and ask a doctor if

Condition worsens or does not improve within 3-5 days
Rash,irritation, or other allergic reaction develops

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

Directions
Clean the affected area before application.
Apply a small amount of the ointment to the affected area 1 to 3 times daily, or as directed by a
healthcare provider.
May cover with a sterile bandage if desired.
Wash hands after use.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/26/2025

Store in a cool, dry place (59-86°F/15-30°C)
Close the cap tightly after use

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/23/2025

Questions or comments?
Contact us at:
support@tagridstore.com

Distributed by TAGRID LLC
San Francisco, CA, USA 94131
Website: tagridstore.com

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Beeswax,

Calendula officinalis Flower Extract,
Cocos nucifera (Coconut) Oil,

Gossypium herbaceum (Cotton) Seed Oil,

Simmondsia chinensis (Jojoba) Seed Oil,

Magnesium Oxide,
Medium Chain Triglycerides,

Mentha piperita
(Peppermint) Oil,

Salvia officinalis (Sage) Oil,

Silver Stearate,

Helianthus annuus (Sunflower) Seed Oil,
Melaleuca alternifolia (Tea Tree) Leaf Oil,

Thuja occidentalis Leaf Extract,

Zinc Oxide.

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