Antiseptic Pain Relieving: Package Insert and Label Information

ANTISEPTIC PAIN RELIEVING- benzalkonium chloride and benzocaine spray
Walgreens

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.

Active ingredient Purpose
Benzocaine USP 20%…………………………………External analgesic

Benzalkonium Chloride 0.1%………………………First Aid Antiseptic

Uses

Temporarily relieves pain and itching due to: • sunburn • minor burns • minor cuts • scrapes • insect bites • minor skin irritations• first aid to help prevent infection in minor cuts, scrapes, bites and burns

Warnings
For external use only.

Flammable: Do not use while smoking or near heat or flame Do not use in large quantities, particularly over raw surfaces or blistered areas
When using this product
• keep out of eyes
• do not apply over large areas of the body or in large quantites. in case of deep or puncture wounds, animal bites, or serious burns, concult a doctor
Stop use and ask doctor if
• condition gets worse • symptoms last more than 7 days
• symptoms clear up and occur again in a few days

•do not use longer than 1 week unless directed by doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor

Inactive Ingredients:
Alcohol Denat.
Diisopropyl Adipate
Propylene Glycol
Tocopheryl Acetate

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ANTISEPTIC PAIN RELIEVING
benzalkonium chloride 0.10% benzocaine 20.00% spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7779
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride (BENZALKONIUM) Benzalkonium Chloride 0.1 g in 100 g
Benzocaine (BENZOCAINE) Benzocaine 20 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
Diisopropyl Adipate
Propylene Glycol
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-7779-03 85 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/31/2017
Labeler — Walgreens (008965063)
Registrant — Product Quest Mfg (927768135)
Establishment
Name Address ID/FEI Operations
Product Quest Mfg 927768135 manufacture (0363-7779), label (0363-7779)

Revised: 04/2018 Walgreens

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