SPL v2
SPL
SPL Set ID 224b8f18-e4f9-4436-98d5-2dab36548f0c
Route
TOPICAL
Published
Effective Date 2022-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (100 mg)
Inactive Ingredients
Aloe Vera Leaf Cetyl Alcohol Glycerin Methylparaben Mineral Oil Potassium Phosphate, Monobasic Propylparaben Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-05-30

Description

Trolamine Salicylate 10%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Trolamine Salicylate 10%

Uses

temporary relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps
Directions
  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily

children 12 years and younger: ask a doctor

Warnings 

For external use only 

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

Active Ingredient

Trolamine Salicylate 10%

Inactive Ingredient

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water (purified)

Other Information 

Store at controlled room temperature 20- 25°C ( 68 - 77°F) 

Close the cap tightly after use

When Using This Product

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • do not use at the same time as other topical analgesics
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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Primary Panel Tube 

Kroger       NDC  30142-730-85

Maximum Strength

PAIN RELIEVING CREAM 

Trolamine Salicylate 10%

NET WT 3 OZ (85 G)

Principal Primary Panel Carton 

Kroger NDC 30142-730-85

Maximum Strength

PAIN RELIEVING CREAM

Trolamine Salicylate 10%

NET WT 3 OZ (85 G)


Structured Label Content

Uses

temporary relieves minor pain associated with:

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

Topical analgesic

Directions
  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily

children 12 years and younger: ask a doctor

Warnings 

For external use only 

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

Active Ingredient

Trolamine Salicylate 10%

Inactive Ingredient (Inactive ingredient)

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water (purified)

Other Information  (Other information )

Store at controlled room temperature 20- 25°C ( 68 - 77°F) 

Close the cap tightly after use

When Using This Product (When using this product)

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • do not use at the same time as other topical analgesics
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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional 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.

Principal Primary Panel Tube  (Principal Primary Panel -Tube )

Kroger       NDC  30142-730-85

Maximum Strength

PAIN RELIEVING CREAM 

Trolamine Salicylate 10%

NET WT 3 OZ (85 G)

Principal Primary Panel Carton  (Principal Primary Panel -Carton )

Kroger NDC 30142-730-85

Maximum Strength

PAIN RELIEVING CREAM

Trolamine Salicylate 10%

NET WT 3 OZ (85 G)


Advanced Ingredient Data


Raw Label Data

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