Theraice Tm

Theraice Tm
SPL v2
SPL
SPL Set ID 088b81e4-76c8-6680-e063-6294a90acb73
Route
TOPICAL
Published
Effective Date 2023-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.04 g)
Inactive Ingredients
Alcohol 95% Trolamine Water Silicon Dioxide Ilex Paraguariensis Leaf Isopropyl Myristate .alpha.-tocopherol, D- Aloe Vera Leaf Glycerin Fd&c Yellow No. 5 Fd&c Blue No. 1 Camphor (synthetic) Green Tea Leaf Carbomer Homopolymer, Unspecified Type Frankincense Arnica Montana Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-27

Description

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Uses

■ For temporary relief of minor aches and pains of muscles and joints

Section 51945-4

Bottle label:

---

Bag (1 bottle) label:

---

Bag (3 bottles) label:

Section 53413-1

www.theraice.com

Warnings

For External Use Only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have: Sensitive skin

Directions

■ Adults and children 12 years of age and older:

Rub a thin film over affected areas not more than 4 times daily; massage not necessary

■ Children under 12 years of age: Consult Physician

Active Ingredient

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

When Using This Product

■ Avoid contact with eyes or mucous membranes ■ Do not apply to wounds or damaged skin ■ Do not use with other ointments, creams, sprays or liniments ■ Do not apply to irritated skin or if excessive irritation develops ■ Do not bandage ■ Wash hands after use with cool water ■ Do not use with heating pad or device ■ Store in a cool dry place

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children

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


Structured Label Content

Uses

■ For temporary relief of minor aches and pains of muscles and joints

Section 51945-4 (51945-4)

Bottle label:

---

Bag (1 bottle) label:

---

Bag (3 bottles) label:

Section 53413-1 (53413-1)

www.theraice.com

Purpose

Topical Analgesic

Warnings

For External Use Only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have: Sensitive skin

Directions

■ Adults and children 12 years of age and older:

Rub a thin film over affected areas not more than 4 times daily; massage not necessary

■ Children under 12 years of age: Consult Physician

Active Ingredient

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

When Using This Product (When using this product)

■ Avoid contact with eyes or mucous membranes ■ Do not apply to wounds or damaged skin ■ Do not use with other ointments, creams, sprays or liniments ■ Do not apply to irritated skin or if excessive irritation develops ■ Do not bandage ■ Wash hands after use with cool water ■ Do not use with heating pad or device ■ Store in a cool dry place

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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


Advanced Ingredient Data


Raw Label Data

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