FIRST AID AND BURN cream

First aid and Burn by

Drug Labeling and Warnings

First aid and Burn by is a Otc medication manufactured, distributed, or labeled by B8 Sales, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

First Aid & Burn CreamTM

• For Temporary Relief of Pain Associated with Minor Burns
• Helps Protect Against Harmful Bacteria

25 Packets

Each Packet Net.Wt.0.9gm

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCI 0.5%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

• for the temporary relief of pain associated with minor bums
• helps protect against harmful bacteria

Warnings

For external use only.

Keep out of reach of children.

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

Do not use

• in eyes ■ in large quantities ■ over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
• for more than one week unless directed by a doctor

Stop use and ask a doctor if

• the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years and over: clean affected area, apply small amount not more than 3 to 4 times daily Children under 2 years: do not use, consult a doctor

Other information

• store at room temperature (do not freeze)
• do not use any opened or torn packets

Inactive ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Principal Display Panel

First Aid & Burn Cream – Carton Label

PIO Put it on®

First Aid & Burn CreamTM

• For Temporary Relief of Pain Associated with Minor Burns
• Helps Protect Against Harmful Bacteria

25 Packets

Each Packet Net.Wt.0.9gm

INGREDIENTS AND APPEARANCE

FIRST AID AND BURN 
first aid and burn cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50607-5700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	1.3 mg  in 1 g
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
aloe (UNII: V5VD430YW9)
alcohol (UNII: 3K9958V90M)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
petrolatum (UNII: 4T6H12BN9U)
white wax (UNII: 7G1J5DA97F)

Product Characteristics
Color	white (white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50607-5700-1	25 in 1 BOX
1		.9 g in 1 POUCH
2	NDC: 50607-5700-2	144 in 1 BOX
2		.9 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	05/01/2010

Labeler - B8 Sales, Inc. (833208635)