FIRST AID ONLY STING RELIEF PAD- benzocaine swab

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

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Active ingredient:
Benzocaine, 6% w/v, Isopropyl Alcohol 60% w/v
Available from:
Acme United Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Anesthetic Antiseptic Use For the temporary relief of pait and itching associated with minor burns, scrapes and insect bites. First aid to help prevent infection in minor cuts, scrapes, and burns
Authorization status:
OTC monograph not final
Authorization number:
0924-5203-01, 0924-5203-02, 0924-5203-03, 0924-5203-04

FIRST AID ONLY STING RELIEF PAD- benzocaine swab

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.

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First Aid Only Sting Relief Pad

Active Ingredients

Benzocaine, 6% w/v

Isopropyl Alcohol 60% w/v

Purpos e

Topical Anesthetic

Antiseptic

Us e

For the temporary relief of pait and itching associated with minor burns, scrapes and insect bites. First

aid to help prevent infection in minor cuts, scrapes, and burns

Directions

▪adults and children 2 years of age or older, apply to affected area not more than 3 to 4 times daily

▪children under 2 years: consult a physician

Warnings

For external use only

Flammable, keep away from fire or flames

Do not use

In the eyes. If contact occurs, rinse thoroughly with water

over large areas of the body

Stop use

If irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets

worse.

Keep out of reach of children.

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

Inactive Ingredients

Purified Water

Other Information

Store at room temperature

Principal Display Panel - 0.4 mL Pouch Label

0.4 mL Pouch Label

FIRST AID ONLY STING RELIEF PAD

benzocaine swab

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 24-520 3(NDC:6 5517-0 0 0 5)

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

6 0 mg in 1 mL

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -

UNII:ND2M416 30 2)

ISOPROPYL

ALCOHOL

0 .6 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 9 24-520 3-0 1

0 .4 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 8 /20 19

2

NDC:0 9 24-520 3-0 2

10 in 1 BOX

0 4/0 8 /20 19

2

0 .4 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:0 9 24-520 3-0 3

25 in 1 BOX

0 4/0 8 /20 19

3

NDC:0 9 24-520 3-0 1

0 .4 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:0 9 24-520 3-0 4

10 0 in 1 BOX

0 4/0 8 /20 19

Acme United Corporation

4

NDC:0 9 24-520 3-0 1

0 .4 mL in 1 POUCH; 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 24-520 3) , repack(0 9 24-520 3)

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 24-520 3) , repack(0 9 24-520 3)

Revised: 4/2019

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