Aramark Burn Gel: Package Insert and Label Information

ARAMARK BURN GEL- lidocaine hydrochloride gel
Western First Aid Safety DBA Aramark

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.

Drug Facts

Active Ingredients

Lidocaine HCL 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for minor burns. For

professional use only.

Warnings

For external use only.

Keep out of reach of children.

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

Do not use

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

Stop use and ask a doctor if

• the condition worsens or symptoms persist for more

than 7 days or clear up and occur again within a few days

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: do not use, consult a doctor

Other Information

• store at room temperature (do not freeze)

• do not use any open or torn packets

Inactive ingredients

aloe vera, carbomer, germaben II, menthol,

propylene glycol, purified water, triethanolamine,

vitamin E acetate

Questions od Comments?

1-800-456-7077

Package Labeling

aramark

25 ct. Each Packet Net. Wt. 0.9g

BURN GEL For Temporary Pain Relief of Minor Burns

aramarkuniform.com

MANUFACTURED FOR:
Aramark
Lenexa, KS 66219

886-362-2691

Please retain carton for drug information.

5000-5 Burn Gel Box
(click image for full-size original)
5000-5 Burn Gel Pouch
(click image for full-size original)

res

ARAMARK BURN GEL
lidocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81238-5000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
DIAZOLIDINYL UREA
MENTHOL
PROPYLENE GLYCOL
WATER
TROLAMINE
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81238-5000-5 25 POUCH in 1 BOX contains a POUCH
1 1 g in 1 POUCH This package is contained within the BOX (81238-5000-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/28/2021
Labeler — Western First Aid Safety DBA Aramark (043861524)
Registrant — Western First Aid Safety DBA Aramark (043861524)
Establishment
Name Address ID/FEI Operations
Safetec of America, Inc. 874965262 MANUFACTURE (81238-5000)

Revised: 09/2021 Western First Aid Safety DBA Aramark

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