155216ae-46ea-4774-e063-6394a90a4704

SPL v1
SPL
SPL Set ID 155216ae-46ea-4774-e063-6394a90a4704
Route
topical
Published
Effective Date 2024-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (natural) (3.1 g) menthol (5.3 g)
Inactive Ingredients
cannabis sativa seed oil grape seed oil clove oil coconut oil yellow wax hemp almond oil cocoa butter cajuput oil peppermint chinese cinnamon oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-04-04

Purpose

Camphor 3.1%.....................Topical Analgesic Menthol 5.3%.......................Topical Analgesic

Description

Camphor 3.1% Menthol 5.3%


Medication Information

Warnings

For external use only

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Camphor 3.1%.....................Topical Analgesic

Menthol 5.3%.......................Topical Analgesic

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

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

Description

Camphor 3.1% Menthol 5.3%

Questions?

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

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

Regular Strength

Dragon Pain Relieving Balm

Isolate

Menthol 5.3% | Camphor 3.1%

96mg CBD

Net Wt 0.5oz (14g)

Section 53414-9

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

Active Ingredients

Camphor 3.1%

Menthol 5.3%


Structured Label Content

Warnings

For external use only

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Camphor 3.1%.....................Topical Analgesic

Menthol 5.3%.......................Topical Analgesic

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

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

Questions?

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

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)

Regular Strength

Dragon Pain Relieving Balm

Isolate

Menthol 5.3% | Camphor 3.1%

96mg CBD

Net Wt 0.5oz (14g)

Section 53414-9 (53414-9)

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

Active Ingredients (Active ingredients)

Camphor 3.1%

Menthol 5.3%


Advanced Ingredient Data


Raw Label Data

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