Reed Therapeutics Pain Relieving Therapy

Reed Therapeutics Pain Relieving Therapy
SPL v2
SPL
SPL Set ID 99dcdb92-58f3-4f10-8f4d-d7a1b927e6ce
Route
TOPICAL
Published
Effective Date 2013-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (12.5 g) Menthol (4 g) Camphor (synthetic) (0.2 g)
Inactive Ingredients
Carbomer 940 Dmdm Hydantoin Fd&c Blue No. 1 Ilex Paraguariensis Whole Methylparaben Propylparaben Tea Tree Oil Thyme Oil Trolamine Water Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-03-23

Description

Active Ingredient,                                 Purpose Methyl Salicylate 12.5%,                 Topical Analgesic/Anti-Inflammatory Menthol USP 4%,                            Topical Analgesic Camphor 0.2%,                               Topical Analgesic, Anti-Inflammatory


Medication Information

Description

Active Ingredient,                                 Purpose Methyl Salicylate 12.5%,                 Topical Analgesic/Anti-Inflammatory Menthol USP 4%,                            Topical Analgesic Camphor 0.2%,                               Topical Analgesic, Anti-Inflammatory

Uses

Temporary relief of minor aches and pains of sore muscles and joints associated with: arthritis, backache, bursitis, muscle cramp, muscle strain and sprains, plantar fasciitis, tendonitis

Section 51945-4

Warnings

For external use only. Keep away from excessive heat or open flame.

If pregnant or breast-feeding: Ask healthcare professional before use.

Directions

Adults and children 12 years and older: Gently masssage and apply to affected area 3-4 times daily. Massage not necessary but may enhance relief.

Children under 12 years of age: Consult a physician.

Drug Facts

Active Ingredient,                                 Purpose

Methyl Salicylate 12.5%,                 Topical Analgesic/Anti-Inflammatory

Menthol USP 4%,                            Topical Analgesic

Camphor 0.2%,                               Topical Analgesic, Anti-Inflammatory

Other Information

Store at controlled room temperature 68' to 77' F. Close cap after use.

Inactive Ingredients

Carbomer 940, DMDM Hydantoin, FD&C Blue #1, Paraguariensis Extract, Methylparaben, Propyparaben, Tea Tree Oil, Thyme Oil, Triethanolamine, Water(D.I), FD&C Yellow#5

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 bandage

Do not use with heating pad or device

Do not use with other ointments, creams, sprays, or liniments

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

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

Keep Out of Reach of Children

If accidently ingested, seek medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

Temporary relief of minor aches and pains of sore muscles and joints associated with: arthritis, backache, bursitis, muscle cramp, muscle strain and sprains, plantar fasciitis, tendonitis

Section 51945-4 (51945-4)

Warnings

For external use only. Keep away from excessive heat or open flame.

If pregnant or breast-feeding: Ask healthcare professional before use.

Directions

Adults and children 12 years and older: Gently masssage and apply to affected area 3-4 times daily. Massage not necessary but may enhance relief.

Children under 12 years of age: Consult a physician.

Drug Facts

Active Ingredient,                                 Purpose

Methyl Salicylate 12.5%,                 Topical Analgesic/Anti-Inflammatory

Menthol USP 4%,                            Topical Analgesic

Camphor 0.2%,                               Topical Analgesic, Anti-Inflammatory

Other Information

Store at controlled room temperature 68' to 77' F. Close cap after use.

Inactive Ingredients

Carbomer 940, DMDM Hydantoin, FD&C Blue #1, Paraguariensis Extract, Methylparaben, Propyparaben, Tea Tree Oil, Thyme Oil, Triethanolamine, Water(D.I), FD&C Yellow#5

When Using This Product (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 bandage

Do not use with heating pad or device

Do not use with other ointments, creams, sprays, or liniments

Stop Use and Ask A Doctor If (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

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

Keep Out of Reach of Children (Keep out of reach of children)

If accidently ingested, seek medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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