SPL v2
SPL
SPL Set ID 154fd46e-f00d-1772-e063-6394a90aba7d
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
Cajuput Oil Grape Seed Oil Cannabis Sativa Seed Oil Clove Oil Chinese Cinnamon Oil Coconut Oil Yellow Wax Hemp Almond Oil Cocoa Butter Peppermint

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%

600mg CBD

50mg CBN

50mg CBG

<.3% THC

Net Wt 2oz (56.7g)

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

almond oil, beeswax, cajaput oil, cassia oil, clove oil, cocoa butter, coconut oil, grapeseed oil, hemp extract, hempseed oil, peppermint


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%

600mg CBD

50mg CBN

50mg CBG

<.3% THC

Net Wt 2oz (56.7g)

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)

almond oil, beeswax, cajaput oil, cassia oil, clove oil, cocoa butter, coconut oil, grapeseed oil, hemp extract, hempseed oil, peppermint


Advanced Ingredient Data


Raw Label Data

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