drug facts

drug facts
SPL v7
SPL
SPL Set ID 1588244a-c9e8-4a04-b605-10e35c225e6c
Route
topical
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
witch hazel (86 g)
Inactive Ingredients
alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-08-31

Purpose

Astringent

Description

Witch hazel, USP 86%


Medication Information

Warnings
  • for external use only
  • avoid swallowing
Uses
  • for relief of minor skin irritations due to:
    • insect bites
    • minor cuts
    • minor scrapes
Purpose

Astringent

Directions

apply to the affected area as often as necessary.

Other Information
  • keep tightly closed
  • store at room temperature
Description

Witch hazel, USP 86%

Principal Display Panel

Distilled extract of

Witch Hazel

Astringent

alcohol 14% by volume

hamamelis  water

for relief of minor skin irritations due to

  • insect bites
  • minor cuts
  • minor scrapes

fl oz (PT) mL

Manufactured by:

PL Developments

513 Old Griffen Road

Piedmont, SC 29673

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Package Label
READYinCASE Astringent
Active Ingredient

Witch hazel, USP 86%

Inactive Ingredient

alcohol 14% by volume

When Using This Product
  • avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
Stop Use and Ask A Doctor If

condition worsens or symptoms persist for more than 7 days.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Warnings
  • for external use only
  • avoid swallowing
Uses
  • for relief of minor skin irritations due to:
    • insect bites
    • minor cuts
    • minor scrapes
Purpose

Astringent

Directions

apply to the affected area as often as necessary.

Other Information (Other information)
  • keep tightly closed
  • store at room temperature
Principal Display Panel

Distilled extract of

Witch Hazel

Astringent

alcohol 14% by volume

hamamelis  water

for relief of minor skin irritations due to

  • insect bites
  • minor cuts
  • minor scrapes

fl oz (PT) mL

Manufactured by:

PL Developments

513 Old Griffen Road

Piedmont, SC 29673

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Package Label
READYinCASE Astringent
Active Ingredient (Active ingredient)

Witch hazel, USP 86%

Inactive Ingredient (Inactive ingredient)

alcohol 14% by volume

When Using This Product (When using this product)
  • avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens or symptoms persist for more than 7 days.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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