9e5d736d-0f07-416c-aca1-636b0fd0a04f

SPL v1
SPL
SPL Set ID 9e5d736d-0f07-416c-aca1-636b0fd0a04f
Route
topical
Published
Effective Date 2016-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
allantoin (0.5 g)
Inactive Ingredients
aloe vera leaf lanolin oil acetylated lanolin isopropyl linoleate glyceryl monostearate peg-100 stearate marine collagen, soluble stearic acid cetyl alcohol stearyl alcohol .alpha.-tocopherol acetate methylpropanediol edetate sodium caprylyl glycol potassium sorbate phenylpropanol trolamine

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2016-06-14

Purpose

SKIN PROTECTANT

Description

ALLANTOIN 0.5%


Medication Information

Warnings

FOR EXTERNAL USE ONLY

Uses

HELPS PREVENT AND RELIEVE SKIN IRRITATION, REDNESS AND PAIN, SUCH AS SYMPTOMS CAUSED BY RADIATION THERAPY OR DERMATOLOGICAL PROCEDURES.

Purpose

SKIN PROTECTANT

Directions

APPLY A SMALL AMOUNT OF ALRA THERAPY LOTION TO THE AFFECTED AREA TWICE DAILY OR AS DIRECTED BY PHYSICIAN.

Inactive Ingredients

100% ALOE VERA (NO WATER), LANOLIN OIL, ACETYLATED LANOLIN, ISOPROPYL LANOLATE, GLYCEROL STEARATE, PEG-100 STEARATE, SOLUBLE COLLAGEN, STEARIC ACID, CETYL ALCOHOL, STEARYL ALCOHOL, TOCOPHERYL ACETATE, METHYLPROPANEDIOL, TETRASODIUM EDTA, CAPRYLYL GLYCOL, POTASSIUM SORBATE, PHENYLPROPANOL, TRIETHANOLAMINE

Description

ALLANTOIN 0.5%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

STOP USE AND ASK A DOCTOR IF

  • CONDITIONS WORSEN
  • SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS
Section 50567-7

WHEN USING THIS PRODUCT

  • DO NOT GET INTO EYES
Section 50570-1

DO NOT USE ON

  • DEEP OR PUNCTURE WOUNDS
  • ANIMAL BITES
  • SERIOUS BURNS
Section 51945-4

Active Ingredients

ALLANTOIN 0.5%

Questions Or Comments?

CALL 1-877-265-9092

WWW.ALRA.COM


Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Uses (USES)

HELPS PREVENT AND RELIEVE SKIN IRRITATION, REDNESS AND PAIN, SUCH AS SYMPTOMS CAUSED BY RADIATION THERAPY OR DERMATOLOGICAL PROCEDURES.

Purpose (PURPOSE)

SKIN PROTECTANT

Directions (DIRECTIONS)

APPLY A SMALL AMOUNT OF ALRA THERAPY LOTION TO THE AFFECTED AREA TWICE DAILY OR AS DIRECTED BY PHYSICIAN.

Inactive Ingredients (INACTIVE INGREDIENTS)

100% ALOE VERA (NO WATER), LANOLIN OIL, ACETYLATED LANOLIN, ISOPROPYL LANOLATE, GLYCEROL STEARATE, PEG-100 STEARATE, SOLUBLE COLLAGEN, STEARIC ACID, CETYL ALCOHOL, STEARYL ALCOHOL, TOCOPHERYL ACETATE, METHYLPROPANEDIOL, TETRASODIUM EDTA, CAPRYLYL GLYCOL, POTASSIUM SORBATE, PHENYLPROPANOL, TRIETHANOLAMINE

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF

  • CONDITIONS WORSEN
  • SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS
Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT

  • DO NOT GET INTO EYES
Section 50570-1 (50570-1)

DO NOT USE ON

  • DEEP OR PUNCTURE WOUNDS
  • ANIMAL BITES
  • SERIOUS BURNS
Section 51945-4 (51945-4)

Active Ingredients (ACTIVE INGREDIENTS)

ALLANTOIN 0.5%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

CALL 1-877-265-9092

WWW.ALRA.COM


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)