drug facts

drug facts
SPL v1
SPL
SPL Set ID 59b4a7d3-5805-4d0f-8080-9efc5813dc49
Route
topical
Published
Effective Date 2019-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (100 mg)
Inactive Ingredients
water coconut alkanes glyceryl monostearate peg-100 stearate cetostearyl alcohol dimethyl sulfone stearic acid glycerin horse chestnut rosa moschata seed oil 3-((l-menthyl)oxy)propane-1,2-diol sorbitan olivate cannabidiol medium-chain triglycerides cetearyl olivate phenoxyethanol menthyl lactate, (-)- tocopherol peppermint oil cetyl palmitate sorbitan monopalmitate coco-caprylate/caprate caprylyl glycol menthol xanthan gum ethylhexylglycerin hexylene glycol vanillyl butyl ether

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-10-16

Description

Active Ingredients: Trolamine Salicylate - 10%


Medication Information

Warnings and Precautions

Warning: For external use only.

Active Ingredient

Active Ingredients:

Trolamine Salicylate - 10%

Indications and Usage

Uses: Temporarily relieves minor pain associated with arthritis, backache, muscle strains, muscle sprains, bruises, cramps. 

Dosage and Administration

Adults and Children over 12 years: Apply generously to affected area. Massage into painful area until thoroughly asborbed into skin. Repeat as necessary, But no more than 4 times daily.

Description

Active Ingredients: Trolamine Salicylate - 10%

Section 50565-1

Keep out of reach of children. If product swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if condition worsens. Symptoms persist for more than 7 days or clear up and occur again within a few days. Redness is persistent. Irritation develops.

Section 50567-7

When using this product: Use only as directed. Read and follow all directions and warnings on this label. Do not bandage tightly or use with a heated pad. Avoid contact with eyes or mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. Do not use at the same time with other topical analgesics.

Section 50569-3

Allergy alert if prone to allergic reaction from aspirin or salicylates, consult a Doctor before use.

Section 51727-6

Inactive ingredients: Water, Coconut Alkanes, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Methyl Sulfonyl Methane, Stearic Acid, Glycerin, Aesculus Hippocastannum (Horse Chestnut) Seed Extract, Rosa Moschata Seed Oil, Menthoxypropanediol, Sorbitan Olivate, Cannabidiol (From full spectrum hemp extract), Medium Chain Triglyceride, Cetearyl Olivate, Phenoxyethanol, Menthyl Lactate, Tocopherol, Mentha Piperita (Pepperment) Oil, Cetyl Palmitate, Sorbitan Palmitate, Coco-Caprylate/Caprate, Caprylyl Glycol, Menthol, Xanthan Gum, Ethylhexylglycerin, Hexylene Glycol, Vanillyl Butyl Ether.

Section 51945-4

Manufactured for:

CBD Therapeutics, LLC

Salt Lake City, UT 84116

Section 53413-1

Questions or Comments? 

Call our customer service department at: 1-800-898-5153 

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose:

Topical Analgesic


Structured Label Content

Warnings and Precautions (34071-1)

Warning: For external use only.

Active Ingredient (55106-9)

Active Ingredients:

Trolamine Salicylate - 10%

Indications and Usage (34067-9)

Uses: Temporarily relieves minor pain associated with arthritis, backache, muscle strains, muscle sprains, bruises, cramps. 

Dosage and Administration (34068-7)

Adults and Children over 12 years: Apply generously to affected area. Massage into painful area until thoroughly asborbed into skin. Repeat as necessary, But no more than 4 times daily.

Section 50565-1 (50565-1)

Keep out of reach of children. If product 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. Symptoms persist for more than 7 days or clear up and occur again within a few days. Redness is persistent. Irritation develops.

Section 50567-7 (50567-7)

When using this product: Use only as directed. Read and follow all directions and warnings on this label. Do not bandage tightly or use with a heated pad. Avoid contact with eyes or mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. Do not use at the same time with other topical analgesics.

Section 50569-3 (50569-3)

Allergy alert if prone to allergic reaction from aspirin or salicylates, consult a Doctor before use.

Section 51727-6 (51727-6)

Inactive ingredients: Water, Coconut Alkanes, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Methyl Sulfonyl Methane, Stearic Acid, Glycerin, Aesculus Hippocastannum (Horse Chestnut) Seed Extract, Rosa Moschata Seed Oil, Menthoxypropanediol, Sorbitan Olivate, Cannabidiol (From full spectrum hemp extract), Medium Chain Triglyceride, Cetearyl Olivate, Phenoxyethanol, Menthyl Lactate, Tocopherol, Mentha Piperita (Pepperment) Oil, Cetyl Palmitate, Sorbitan Palmitate, Coco-Caprylate/Caprate, Caprylyl Glycol, Menthol, Xanthan Gum, Ethylhexylglycerin, Hexylene Glycol, Vanillyl Butyl Ether.

Section 51945-4 (51945-4)

Manufactured for:

CBD Therapeutics, LLC

Salt Lake City, UT 84116

Section 53413-1 (53413-1)

Questions or Comments? 

Call our customer service department at: 1-800-898-5153 

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose:

Topical Analgesic


Advanced Ingredient Data


Raw Label Data

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