REDIBURN BURN GEL SKIN PROTECTANT- burn gel gel
Redicare LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Burn Gel

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

BURN GEL

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	04/15/2017	07/01/2021

Labeler - Redicare LLC (800149346)

Revised: 7/2021

Document Id: c62a2e86-7f5a-45e1-e053-2a95a90af9c4

Set id: 4bcdf2c6-dbdf-558f-e054-00144ff8d46c

Version: 5

Effective Time: 20210702

Redicare LLC