Sera Relief Ultimate Rapid Soothing Creme

Sera Relief Ultimate Rapid Soothing Creme
SPL v1
SPL
SPL Set ID b33a3a3e-195a-42ae-8e70-cfc859376736
Route
TOPICAL
Published
Effective Date 2019-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Allantoin Medium-chain Triglycerides Paprika Edetate Calcium Disodium Anhydrous Cannabis Sativa Subsp. Sativa Flowering Top .alpha.-tocopherol Acetate, Dl- Alcohol Ethylhexylglycerin Ethylhexyl Stearate Glycerin Phenoxyethanol Polysorbate 80 Propanediol Propylene Glycol Water Dimethicone Sodium Polyacrylate (2500000 Mw) Trideceth-6 Grape Seed Oil Xanthan Gum Caryophyllene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-11-04

Description

Lidocaine 4%

Purpose

Topical Analgesic


Medication Information

Warnings and Precautions

Warning: For external use only

Flammable: Keep away from excessive heat or open flame

When using this product: Avoid contact with eyes or mucous membrane. Do not apply to wounds, damaged, blistered or irritated skin. Do not use with other ointments, creams, sprays or liniments. Do not bandage. Wash hands after use with cool water. Do not use with heating pad or device.

Ask a doctor before use if you have sensitive skin. Stop use if condition worsens or persists for more than 7 days.

If pregnant or breast feeding: ask doctor before using

Indications and Usage

Uses: Temporarily relief from minor pain associated with: • arthritis • bruises • simple backache • muscle strains • cramps • sprains

Purpose

Topical Analgesic

Dosage and Administration

Recommended Use: Adults, with container rub a thin film over affected areas, not more than 3-4 times in 24 hour period, massage is not necessary.

Description

Lidocaine 4%

Section 42229-5

Feet & Legs

4% LIDOCAINE

WITH CBD 300mg

Section 44425-7

Other information: store in cool dry place

Section 50565-1

Keep out of reach of children: if accidentally ingested get medical help or contact a Poison Control Center immediately

Section 51727-6

Inactive Ingredients: Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit powder, Calcium Disodium EDTA, Cannabis Sativa (Aerial) Extract Oil, DL-Alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Stearate, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) seed Oil, Xanthan Gum, Beta – Caryophyllene

Packaging

Drug Facts

Active Ingredients

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

Uses: Temporarily relief from minor pain associated with: • arthritis • bruises • simple backache • muscle strains • cramps • sprains

Dosage and Administration (34068-7)

Recommended Use: Adults, with container rub a thin film over affected areas, not more than 3-4 times in 24 hour period, massage is not necessary.

Warnings and Precautions (34071-1)

Warning: For external use only

Flammable: Keep away from excessive heat or open flame

When using this product: Avoid contact with eyes or mucous membrane. Do not apply to wounds, damaged, blistered or irritated skin. Do not use with other ointments, creams, sprays or liniments. Do not bandage. Wash hands after use with cool water. Do not use with heating pad or device.

Ask a doctor before use if you have sensitive skin. Stop use if condition worsens or persists for more than 7 days.

If pregnant or breast feeding: ask doctor before using

Section 42229-5 (42229-5)

Feet & Legs

4% LIDOCAINE

WITH CBD 300mg

Section 44425-7 (44425-7)

Other information: store in cool dry place

Section 50565-1 (50565-1)

Keep out of reach of children: if accidentally ingested get medical help or contact a Poison Control Center immediately

Section 51727-6 (51727-6)

Inactive Ingredients: Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit powder, Calcium Disodium EDTA, Cannabis Sativa (Aerial) Extract Oil, DL-Alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Stearate, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) seed Oil, Xanthan Gum, Beta – Caryophyllene

Purpose

Topical Analgesic

Packaging

Drug Facts

Active Ingredients

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

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