Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e2d2e33d-5bee-46ee-b465-3b386dee2152
Route
TOPICAL
Published
Effective Date 2014-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 g)
Inactive Ingredients
Aloe Vera Leaf Yellow Wax Medium-chain Triglycerides Jojoba Oil Carnauba Wax Shea Butter .alpha.-tocopherol Acetate Tribehenin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-04-01

Description

Active Ingredient Allantoin 0.5%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Not intended as a treatment for rashes, sores or open cuts. Do not ingest or allow contact with eyes. Stop use if rash or irritation occurs.

Indications and Usage

Uses

Helps prevent skin chafing during exercise

Dosage and Administration

Directions

Apply to underarms, inner thighs, toes, heels, sternum, bra line or other areas as necesssary.

Description

Active Ingredient Allantoin 0.5%

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Beeswax, Capric/Caprylic Triglycerides, Simmondsia Chinensis (Jojoba) Seed Oil, Organic Carnauba Wax, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate (Vitamin E), Tribehenin

Section 51945-4

UNSCENTED

All Weather, Any Distance

Ant-Chafe Stick

*Run

Guard

with Aloe

Beeswax and

Organic Carnauba

plus Shea Butter

and Jojoba Oil

Net Weight

2.7 oz (76g)

MADE IN USA

Section 53413-1

Questions?

1-877-369-1600 U.S. toll free

1-734-544-4490 International

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

Allantoin 0.5%


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps prevent skin chafing during exercise

Dosage and Administration (34068-7)

Directions

Apply to underarms, inner thighs, toes, heels, sternum, bra line or other areas as necesssary.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Not intended as a treatment for rashes, sores or open cuts. Do not ingest or allow contact with eyes. Stop use if rash or irritation occurs.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 51727-6 (51727-6)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Beeswax, Capric/Caprylic Triglycerides, Simmondsia Chinensis (Jojoba) Seed Oil, Organic Carnauba Wax, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate (Vitamin E), Tribehenin

Section 51945-4 (51945-4)

UNSCENTED

All Weather, Any Distance

Ant-Chafe Stick

*Run

Guard

with Aloe

Beeswax and

Organic Carnauba

plus Shea Butter

and Jojoba Oil

Net Weight

2.7 oz (76g)

MADE IN USA

Section 53413-1 (53413-1)

Questions?

1-877-369-1600 U.S. toll free

1-734-544-4490 International

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Allantoin 0.5%


Advanced Ingredient Data


Raw Label Data

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