sunmed motion

sunmed motion
SPL v1
SPL
SPL Set ID 1ef36715-2b45-441e-9f61-d99b8d553d11
Route
topical
Published
Effective Date 2019-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
allantoin medium-chain triglycerides paprika edetate calcium disodium anhydrous cannabis sativa subsp. sativa flowering top dimethicone .alpha.-tocopherol acetate, dl- alcohol ethylhexylglycerin ethylhexyl stearate glycerin phenoxyethanol polysorbate 80 propanediol propylene glycol water sodium polyacrylate (8000 mw) trideceth-6 grape seed oil xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-08-22

Purpose

Topical Analgesic

Description

Lidocaine 4%


Medication Information

Warnings

For external use only

When using this product

• use only as directed • do not bandage tightly • avoid contact with eyes • do not apply to wounds or damaged skin • do not use in large  quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

• condition worsens • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

Uses

Temporarily relieves minor pain associated with:

• arthritis  • sprains  • simple backache  • muscle strains  • cramps  • bruises

Purpose

Topical Analgesic

Directions

• Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.

• Children under 2 years of age: Consult a doctor.

Inactive Ingredients

Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit Powder, Calcium Disodium EDTA, Cannabis Sativa (Aerial) Extract Oil, Dimethicone, dl-alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Stearate, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) Seed Oil, Xanthan Gum.

Description

Lidocaine 4%

Section 42229-5

Visit us at SUNFLORA.org

This product has not been evaluated by the Food & Drug Administration and is not intended to diagnose, treat, cure, or prevent any disease. Consult your physician before use. For adults 18+.

DISTRIBUTED BY:

SunFlora, Inc.

411 19th street S

St.  Petersberg, FL 

Packaging

Drug Facts

Active Ingredients

Lidocaine 4%

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only

When using this product

• use only as directed • do not bandage tightly • avoid contact with eyes • do not apply to wounds or damaged skin • do not use in large  quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

• condition worsens • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

Uses

Temporarily relieves minor pain associated with:

• arthritis  • sprains  • simple backache  • muscle strains  • cramps  • bruises

Purpose

Topical Analgesic

Directions

• Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.

• Children under 2 years of age: Consult a doctor.

Inactive Ingredients

Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit Powder, Calcium Disodium EDTA, Cannabis Sativa (Aerial) Extract Oil, Dimethicone, dl-alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Stearate, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) Seed Oil, Xanthan Gum.

Section 42229-5 (42229-5)

Visit us at SUNFLORA.org

This product has not been evaluated by the Food & Drug Administration and is not intended to diagnose, treat, cure, or prevent any disease. Consult your physician before use. For adults 18+.

DISTRIBUTED BY:

SunFlora, Inc.

411 19th street S

St.  Petersberg, FL 

Packaging

Drug Facts

Active Ingredients

Lidocaine 4%

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

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


Advanced Ingredient Data


Raw Label Data

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