Label: AFASSCO BURN GEL- lidocaine gel
- NDC Code(s): 51532-3806-1, 51532-3806-2
- Packager: Afassco Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated January 12, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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Package Labeling
Afassco¦ ¦®
The First Choice
in First Aid
AFASSCO
BURN GEL WITH ALOE VERA
FOR FIRST AID USE ON MINOR BURNS, SCALDS, & SUNBURNNo.388 6 ct.
AFASSCO
BURN GELWITH ALOE VERA
6 ct.
AFASSCO
BURN GELWITH ALOE VERA
6 ct.
COOLS, SOOTHES, RELIEVES PAIN. FOR FIRST AID USE
ON MINOR BURNS, SCALDS, AND SUNBURN.INSTRUCTIONS: Apply a generous layer of Burn Gel to the affected area.
Do not rub into skin. The skin should feel cool within 30 minutes.
If the heat persists, reapply as needed. Twice daily use of Burn Gel will
unlock the natural healing power of Aloe Vera to help revitalize the skin.WARNING: If redness or swelling persists for 7 days or if infection or rash develops,
discontinue use and seek medical advice.REFRESCA, ALIVIA, SUAVIZA EL DOLOR, PARA UTILIZAR
COMO PRIMEROS AUXILIOS EN PEQUEÑAS
QUEMADURAS, ESCALDADURAS Y QUEMADURAS DEL SOL.INSTRUCCIONES: Aplique na capa generosa de gel de grabación para la zona
afectada. No se frote en la piel. La piel debe estar frio en 30 minutos. Si el calor
persiste, volver a aplicar según sea necesario. Dos veces el uso diario de gel se
desbloqueará los recursos naturales poder curativo del Aloe Vera para ayudar a
revitalizar la piel.ADVERTENCIAS: Si el enrojecimiento o la hinchazón persisten durante 7 días o si
desarrolla una infección o erupción cutánea, suspenda su uso y consultar al médico.INGREDIENTS: Water, Menthol, Propylene Glycol, Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract.
Afassco¦ ¦® ANSI Z308.1 Manufactured for Afassco, Inc., Minden, NV 89423
6 70254 20388 7
6 Count Box Label
24 Count Box Label
Packet Label
res
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INGREDIENTS AND APPEARANCE
AFASSCO BURN GEL
lidocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-3806 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 70 mg in 3.5 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MENTHOL (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER 1342 (UNII: 809Y72KV36) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51532-3806-1 6 in 1 BOX 08/25/2019 1 3.5 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:51532-3806-2 24 in 1 BOX 08/25/2019 2 3.5 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 08/25/2019 Labeler - Afassco Inc. (609982723) Registrant - Afassco Inc. (956159800) Establishment Name Address ID/FEI Business Operations Yuyao Jessie Commodity Co., Ltd. 529892305 manufacture(51532-3806)