Blue-emu®

Blue-emu®
SPL v3
SPL
SPL Set ID 80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9
Route
TOPICAL
Published
Effective Date 2024-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.1 g)
Inactive Ingredients
Allantoin Aloe Vera Leaf Cannabis Sativa Seed Oil Cetyl Alcohol Dimethicone, Unspecified Edetate Disodium Anhydrous Emu Oil Ethylhexylglycerin Fd&c Blue No. 1 Glucosamine Hydrochloride Glycerin Glyceryl Stearate/peg-100 Stearate Dimethyl Sulfone Mineral Oil Panthenol Phenoxyethanol Polysorbate 80 Stearic Acid Trolamine .alpha.-tocopherol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-05

Description

Trolamine salicylate 10%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Trolamine salicylate 10%

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps
Section 42229-5

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Section 50565-1

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only

Directions

adults and children over 12 years of age:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 12 years or younger: ask a doctor.

Active Ingredient

Trolamine salicylate 10%

Other Information

Store at 68-77°F (20-25°C)

Inactive Ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice (aloe vera), cannabis sativa seed oil, cetyl alcohol, dimethicone, disodium EDTA, emu oil, ethylhexylglycerin, FD & C Blue#1, glucosamine HCl, glycerin, glyceryl stearate and peg-100 stearate, methylsulfonylmethane, mineral oil, panthenol, phenoxyethanol, polysorbate 80, stearic acid, triethanolamine, tocopheryl acetate (Vitamin E), water.

When Using This Product
  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin.
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops.
Principal Display Panel – Carton Label

PAIN RELIEF

ULTRA

 

BLUE-EMU®

-HEMP-

CANNABIS SATIVA

SEED OIL + EMU OIL

 

TOPICAL PAIN RELIEF CREAM

NET WT 3 OZ. (88g)


Structured Label Content

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps
Section 42229-5 (42229-5)

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

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 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Topical analgesic

Warnings

For external use only

Directions

adults and children over 12 years of age:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 12 years or younger: ask a doctor.

Active Ingredient

Trolamine salicylate 10%

Other Information (Other information)

Store at 68-77°F (20-25°C)

Inactive Ingredients (Inactive ingredients)

acrylates/c10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice (aloe vera), cannabis sativa seed oil, cetyl alcohol, dimethicone, disodium EDTA, emu oil, ethylhexylglycerin, FD & C Blue#1, glucosamine HCl, glycerin, glyceryl stearate and peg-100 stearate, methylsulfonylmethane, mineral oil, panthenol, phenoxyethanol, polysorbate 80, stearic acid, triethanolamine, tocopheryl acetate (Vitamin E), water.

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops.
Principal Display Panel – Carton Label (PRINCIPAL DISPLAY PANEL – Carton Label)

PAIN RELIEF

ULTRA

 

BLUE-EMU®

-HEMP-

CANNABIS SATIVA

SEED OIL + EMU OIL

 

TOPICAL PAIN RELIEF CREAM

NET WT 3 OZ. (88g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)