Initial Drug Listing-tagrid Skin Repair Ointment Allantoin 1%

Initial Drug Listing-tagrid Skin Repair Ointment Allantoin 1%
SPL v4
SPL
SPL Set ID 34a8bf10-1c18-1c14-e063-6394a90a0a6f
Route
TOPICAL
Published
Effective Date 2025-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (10 mg)
Inactive Ingredients
Gossypium Herbaceum (cotton) Seed Oil Mentha Piperita (peppermint) Oil Salvia Officinalis (sage) Oil Silver Stearate Zinc Oxide Calendula Officinalis Flower Simmondsia Chinensis (jojoba) Seed Oil Thuja Occidentalis Leaf Cocos Nucifera (coconut) Oil Beeswax Magnesium Oxide Melaleuca Alternifolia (tea Tree) Leaf Oil Medium-chain Triglycerides Sunflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-23

Description

Allantoin 1% (w/w/)


Medication Information

Warnings and Precautions

For external use only

Indications and Usage



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

Dosage and Administration

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.

Description

Allantoin 1% (w/w/)

Section 50565-1



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

Section 50566-9



Stop use and ask a doctor if

Condition worsens or does not improve within 3-5 days

Rash,irritation, or other allergic reaction develops

Section 50567-7

■ 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.

Section 50569-3

Ask a doctor before use if you have:

Deep or puncture wounds

Animal bites

Serious burns

Large areas of damaged skin

Section 50570-1

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

Section 51727-6

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.

Section 51945-4

Available in 30 g, 20 g and 15 g tube. All packages look the same externally, with the only variation being fill volume.

Section 53413-1

Questions or comments?

Contact us at:

[email protected]

Distributed by TAGRID LLC

San Francisco, CA, USA 94131

Website: tagridstore.com

Section 55105-1

Skin protectant

Section 55106-9

Allantoin 1% (w/w/)

Section 60561-8

Store in a cool, dry place (59-86°F/15-30°C)

Close the cap tightly after use


Structured Label Content

Indications and Usage (34067-9)



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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)



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

Section 50566-9 (50566-9)



Stop use and ask a doctor if

Condition worsens or does not improve within 3-5 days

Rash,irritation, or other allergic reaction develops

Section 50567-7 (50567-7)

■ 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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have:

Deep or puncture wounds

Animal bites

Serious burns

Large areas of damaged skin

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Available in 30 g, 20 g and 15 g tube. All packages look the same externally, with the only variation being fill volume.

Section 53413-1 (53413-1)

Questions or comments?

Contact us at:

[email protected]

Distributed by TAGRID LLC

San Francisco, CA, USA 94131

Website: tagridstore.com

Section 55105-1 (55105-1)

Skin protectant

Section 55106-9 (55106-9)

Allantoin 1% (w/w/)

Section 60561-8 (60561-8)

Store in a cool, dry place (59-86°F/15-30°C)

Close the cap tightly after use


Advanced Ingredient Data


Raw Label Data

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