FIRST AID ONLY FIRST AID/ BURN- benzalkonium chloride, lidocaine hydrochloride cream

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
Benzalkonium chloride 0.13%, Lidocaine HCl 0.5%
Available from:
Acme United Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First Aid antiseptic External analgesic First aid to help prevent infection and for the temporary relief of pain and itching associated with - minor cuts - scrapes - burns
Authorization status:
OTC monograph not final
Authorization number:
0924-5711-01, 0924-5711-02, 0924-5711-03, 0924-5711-04, 0924-5711-05, 0924-5711-06, 0924-5711-07, 0924-5711-08, 0924-5711-09, 0924-5711-10, 0924-5711-11, 0924-5711-12, 0924-5711-13, 0924-5711-14

FIRST AID ONLY FIRST AID/ BURN- benzalkonium chloride, lidocaine hydrochloride cream

Acme United Corporation

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.

----------

First Aid Only First Aid/Burn Cream

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

Purpos e

First Aid antiseptic

External analgesic

Us es

First aid to help prevent infection and for the temporary relief of pain and itching associated with

minor cuts

scrapes

burns

Warnings

For external use only.

Do not use

▪in the eyes ▪over large areas of the body ▪in large quantities, particularly over raw surfaces or

blistered areas ▪if you are allergic to any of the ingredients ▪on deep puncture wounds, animal bites, or

serious burns

Ask a doctor before use if you have

deep or puncture wounds, animal bites, or serious burns

When using this product

avoid contact with eyes

Stop use and ask a doctor if

▪condition worsens or clears up and occurs again within a few days

▪symptoms persist for more than 7 days

▪a rash or allergic reaction occurs

Keep out of the reach of children.

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

Other information

Store at room temperature

Directions

Adults - Clean the affected area, apply a small amount of product (equal to the surface area of a

fingertip) 1 to 3 times daily.

Children under 2- Consult a doctor

Inactive ingredients

aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate,

methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water,

stearic acid, triethanolamine

Ques tions ?

1-800-835-2263

Carton Image

FIRST AID ONLY FIRST AID/ BURN

benzalkonium chloride, lidocaine hydrochloride cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 24-5711(NDC:59 8 9 8 -9 0 2)

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM CHLORIDE

0 .13 g

in 10 0 g

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -

UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

0 .5 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

WATER (UNII: 0 59 QF0 KO0 R)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 9 24-5711-0 4

10 in 1 CARTON

0 4/0 8 /20 19

1

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 9 24-5711-0 2

6 in 1 CARTON

0 4/0 8 /20 19

2

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:0 9 24-5711-0 3

6 in 1 BAG

0 4/0 8 /20 19

3

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:0 9 24-5711-0 1

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 8 /20 19

5

NDC:0 9 24-5711-0 5

10 in 1 CARTON

0 4/0 8 /20 19

5

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

6

NDC:0 9 24-5711-0 6

12 in 1 CARTON

0 4/0 8 /20 19

6

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

7

NDC:0 9 24-5711-0 7

20 in 1 CARTON

0 4/0 8 /20 19

7

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

8

NDC:0 9 24-5711-0 8

20 in 1 CARTON

0 4/0 8 /20 19

8

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

9

NDC:0 9 24-5711-0 9

25 in 1 CARTON

0 4/0 8 /20 19

9

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

10

NDC:0 9 24-5711-10

25 in 1 CARTON

0 4/0 8 /20 19

10

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

11

NDC:0 9 24-5711-11

50 in 1 CARTON

0 4/0 8 /20 19

11

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

12

NDC:0 9 24-5711-12

6 0 in 1 CARTON

0 4/0 8 /20 19

12

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

13

NDC:0 9 24-5711-13

144 in 1 CARTON

0 4/0 8 /20 19

Acme United Corporation

13

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

14

NDC:0 9 24-5711-14

144 in 1 CARTON

0 4/0 8 /20 19

14

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 4/0 8 /20 19

Labeler -

Acme United Corporation (001180207)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Acme United Co rpo ratio n

0 459 24339

relabel(0 9 24-5711) , repack(0 9 24-5711)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Acme United Co rpo ratio n

0 8 0 119 59 9

relabel(0 9 24-5711) , repack(0 9 24-5711)

Revised: 4/2019

Similar products

Search alerts related to this product

View documents history

Share this information