baker's best pain relief cream with pure hemp seed oil

baker's best pain relief cream with pure hemp seed oil
SPL v2
SPL
SPL Set ID ae54c234-bfe4-4a74-b293-db7efda7884b
Route
topical
Published
Effective Date 2023-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (40 mg)
Inactive Ingredients
aloe vera leaf water cannabis sativa seed oil cetyl alcohol emu oil ethylhexylglycerin glucosamine sulfate c13-14 isoparaffin isopropyl myristate laureth-7 dimethyl sulfone methyl salicylate polyethylene glycol 400 phenoxyethanol polysorbate 80 trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-02-03

Purpose

Topical Analgesic

Description

Lidocaine HCl (4.00%) Menthol (1.00%)


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine HCl (4.00%) Menthol (1.00%)

Uses:
  • For the temporary relief of pain, and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.
Warnings:

For external use only

Use only as directed

Do Not Use
  • in large quantities, over raw skin or blistered areas.
  • Avoid contact with eyes. 
  • If symptoms worsen or persist for more than 7 days, then discontinue use and consult a doctor.
  • Do not bandage or apply local heat to area of use.
Directions:

Apply a thin layer to affected area not more than 3 to 4 times in 24 hours. Adults and children over 12 years:

consult a doctor before use. Children under 12 years:

Package Labeling:

Active Ingredients

Lidocaine HCl (4.00%)

Menthol (1.00%)

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Methylsulfonylmethane (MSM), Methyl Salicylate, PEG-8, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Triethanolamine.

Additional Information:
  • Store at room temperature.
If Pregnant Or Breast Feeding,
  • ask a doctor before use,
Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Purpose

Topical Analgesic

Uses:
  • For the temporary relief of pain, and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.
Warnings:

For external use only

Use only as directed

Do Not Use (Do not use)
  • in large quantities, over raw skin or blistered areas.
  • Avoid contact with eyes. 
  • If symptoms worsen or persist for more than 7 days, then discontinue use and consult a doctor.
  • Do not bandage or apply local heat to area of use.
Directions:

Apply a thin layer to affected area not more than 3 to 4 times in 24 hours. Adults and children over 12 years:

consult a doctor before use. Children under 12 years:

Package Labeling:

Active Ingredients

Lidocaine HCl (4.00%)

Menthol (1.00%)

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Methylsulfonylmethane (MSM), Methyl Salicylate, PEG-8, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Triethanolamine.

Additional Information:
  • Store at room temperature.
If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)
  • ask a doctor 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 right away.

Advanced Ingredient Data


Raw Label Data

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