BLUEDOT CALLUS REMOVERS- salicylic acid patch

BLUEDOT Callus Removers by

Drug Labeling and Warnings

BLUEDOT Callus Removers by is a Otc medication manufactured, distributed, or labeled by CREST MEDICAL LIMITED, KRE EOOD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each dosage unit)

Salicylic acid 40% in a plaster vehicle

Purposes

Corn and calluses removal

Uses

For the removal of corns and calluses
Relieves pain by removing corns and calluses
Adhesive bandage holds the medicated pad in position

Warnings

For external use only

Do not use
If you are a diabetic
If you have poor blood circulation
On irritated skin or any area that is infected or reddened

Stop use and ask a doctor if
Discomfort lasts

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

Directions

Wash affected area and dry thoroughly
Apply medicated bandage after 48 hours, remove medicated bandage
Repeat procedure every 48 hours as needed for up to 14 days (until callus is removed)
May soak callus in warm water for 5 minutes to assist in removal

Other information

Store between 0° to 40°C (32° to 104°F)

Inactive ingredients

Acrylic adhesive, Titanium dioxide, Ferric hydroxide

Questions?

1-800-723-2465

SPL UNCLASSIFIED SECTION

Maximum Strength

Medicated

Safe & effective callus removal treatment

Extra thick pads to protect against friction & reduce pressure

DISTRIBUTED BY:
Crest Medical Ltd.
3 Chesford Grange,
Warrington, Cheshire.
WA1 4RQ. UK.

www.crestmedical.co.uk
MADE IN BULGARIA

Packaging

INGREDIENTS AND APPEARANCE

BLUEDOT CALLUS REMOVERS 
salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84713-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	40 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC HYDROXIDE (UNII: 2UA751211N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84713-103-04	1 in 1 BOX	09/15/2024
1		4 in 1 BAG
1		0.0275 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M030	09/15/2024

Labeler - CREST MEDICAL LIMITED (238858539)

Establishment
Name	Address	ID/FEI	Business Operations
KRE EOOD		565504983	manufacture(84713-103) , label(84713-103) , pack(84713-103)