REDIBURN BURN GEL SKIN PROTECTANT- burn gel gel

Rediburn Burn Gel Skin Protectant by

Drug Labeling and Warnings

Rediburn Burn Gel Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Redicare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients.........Purpose

Lidocaine 35mg...........Pain Reliever

Uses

• Protects skin from further damage
• Cools burns
• Relieves pain & Itching

Warnings

For External use Only

Do not use

without medical direction on severe burns that cover more than 10% of the body.

When using this product

take care to replace dressings as often as necessary to prevent sticking to the wound.

Stop use and ask a doctor

if irritation persists or worsens.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions

• Seek medical advice before applying on extreme burns.
• Apply generous amount of gel to the skin.
• Repeat as necessary.
• Cover/wrap burn area if required.

Other information

• Contents sterile until package opened or damaged.
• Gel can be rinsed off with water.

Inactive ingredients

• Propylene glycol
• Glycerine
• Silicone emulsion
• carbomer
• purified water
• tea tree oil
• Aloe

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REDIBURN BURN GEL SKIN PROTECTANT 
burn gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71105-096
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 934 (UNII: Z135WT9208)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71105-096-02	10 in 1 BOX	04/15/2017
1	NDC: 71105-096-01	3.5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 71105-096-04	14 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	04/15/2017
3	NDC: 71105-096-05	15 in 1 BOX	09/15/2017
3	NDC: 71105-096-01	3.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/15/2017

Labeler - Redicare LLC (800149346)

Establishment
Name	Address	ID/FEI	Business Operations
Redicare LLC		800149346	manufacture(71105-096)