SPL v2
SPL
SPL Set ID 155119ee-6266-9f72-e063-6394a90a1229
Route
TOPICAL
Published
Effective Date 2024-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (11 g) Menthol (15 g)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Sunflower Oil Stearyl Alcohol Shea Butter Titanium Dioxide Sodium Hydroxide Peg-100 Stearate Glycerin Ethylhexylglycerin Stearic Acid Aloe Polysorbate 20 Water Tocopherol Isopropyl Palmitate .alpha.-tocopherol Acetate Glyceryl Monostearate Phenoxyethanol Petrolatum Cajuput Oil Cannabis Sativa Seed Oil Clove Oil Hemp Peppermint Oil Chinese Cinnamon Oil Olive Oil Chamomile

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-04

Description

Camphor 11% Menthol 15%

Purpose

Camphor 11%.....................Topical Analgesic Menthol 15%.......................Topical Analgesic


Medication Information

Purpose

Camphor 11%.....................Topical Analgesic

Menthol 15%.......................Topical Analgesic

Description

Camphor 11% Menthol 15%

Uses

For the temporary relief of minor achse and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1

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

Section 50566-9

Stop use and ask doctor if

  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • condition worsens
  • irritation occurs
Section 50567-7

When using this product

  • avoid contact with the eyes
  • do not bandage tightly
Section 50570-1

Do not use

  • on wounds or damaged skin
Section 51945-4

Maximum Strength

Dragon Pain Relieving Balm

Full Spectrum

Menthol 15% | Camphor 11%

1000mg CBD

75mg CBN

75mg CBG

<.3% THC

Net Wt 3.4oz (96.4g)

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: do not use, consult a doctor.
Questions?

888.442.2702 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com

Other Information
  • store in a cool, dry place away from light
Active Ingredients

Camphor 11%

Menthol 15%

Inactive Ingredients

Lotion Base (Water, Sunflower Seed Oil, Isopropyl Palmitate, Stearic Acid, Stearyl Alcohol, Aloe Leaf Juice, Shea Butter, Olea Europaea Olive Fruit Oil, Titanium Dioxide, Tocopheryl Acetate, Chamomilla REcutita Matricaria Flower Extract, Sodium Hydroxide, Glyceryl Stearate, Phenoxyethanol, Petrolatum, PEG-100 Stearate, Carbomer, Glycerin, Ethylhexylglycerin, Tocopherol) Menthol, Camphor, Cajeput Oil, Cassia Oil, Clove Oil, Hemp Seed Oil, Peppermint Oil, Hemp Extracted Oil, Polysorbate 20.


Structured Label Content

Uses

For the temporary relief of minor achse and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if

  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • condition worsens
  • irritation occurs
Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes
  • do not bandage tightly
Section 50570-1 (50570-1)

Do not use

  • on wounds or damaged skin
Section 51945-4 (51945-4)

Maximum Strength

Dragon Pain Relieving Balm

Full Spectrum

Menthol 15% | Camphor 11%

1000mg CBD

75mg CBN

75mg CBG

<.3% THC

Net Wt 3.4oz (96.4g)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

Camphor 11%.....................Topical Analgesic

Menthol 15%.......................Topical Analgesic

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: do not use, consult a doctor.
Questions?

888.442.2702 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com

Other Information (Other information)
  • store in a cool, dry place away from light
Active Ingredients (Active ingredients)

Camphor 11%

Menthol 15%

Inactive Ingredients (Inactive ingredients)

Lotion Base (Water, Sunflower Seed Oil, Isopropyl Palmitate, Stearic Acid, Stearyl Alcohol, Aloe Leaf Juice, Shea Butter, Olea Europaea Olive Fruit Oil, Titanium Dioxide, Tocopheryl Acetate, Chamomilla REcutita Matricaria Flower Extract, Sodium Hydroxide, Glyceryl Stearate, Phenoxyethanol, Petrolatum, PEG-100 Stearate, Carbomer, Glycerin, Ethylhexylglycerin, Tocopherol) Menthol, Camphor, Cajeput Oil, Cassia Oil, Clove Oil, Hemp Seed Oil, Peppermint Oil, Hemp Extracted Oil, Polysorbate 20.


Advanced Ingredient Data


Raw Label Data

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