Family Wellness 063.001/063aa

Family Wellness 063.001/063aa
SPL v20
SPL
SPL Set ID 1a03331e-3676-451c-be22-9a547e8ae6e2
Route
TOPICAL
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ferric Oxide Red (80 mg) Zinc Oxide
Inactive Ingredients
Bentonite Calcium Hydroxide Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1989-07-15

Description

Calamine 8% Zinc oxide 8%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Calamine 8% Zinc oxide 8%

Use

dries the oozing and weeping of poison:

  • ivy 
  • oak 
  • sumac
Warnings

For external use only

Directions
  • shake well before using 
  • apply as needed
Adverse Reaction

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE,VA 23320 USA

MADE IN THE US WITH US AND FOREIGN COMPONENTS

100% SATISFACTION OR YOUR MONEY BACK!

NOT 100% SATISFIED?

Return within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

Other Information

store at 59⁰ - 86⁰F

Active Ingredients

Calamine 8%

Zinc oxide 8%

Inactive Ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Principal Display Panel

FAMILY Wellness™

CALAMINE LOTION

DRYING

Calamine Topical Suspension USP

POISON IVY, OAK, AND SUMAC DRYING LOTION

  • Skin Protectant
  • Shake Well Before Using

6 FL OZ (177 mL)

NDC 55319-063-30

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

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


Structured Label Content

Use

dries the oozing and weeping of poison:

  • ivy 
  • oak 
  • sumac
Purpose

Skin Protectant

Warnings

For external use only

Directions
  • shake well before using 
  • apply as needed
Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE,VA 23320 USA

MADE IN THE US WITH US AND FOREIGN COMPONENTS

100% SATISFACTION OR YOUR MONEY BACK!

NOT 100% SATISFIED?

Return within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

Other Information (Other information)

store at 59⁰ - 86⁰F

Active Ingredients (Active ingredients)

Calamine 8%

Zinc oxide 8%

Inactive Ingredients (Inactive ingredients)

bentonite magma, calcium hydroxide, glycerin, purified water

Principal Display Panel (Principal display panel)

FAMILY Wellness™

CALAMINE LOTION

DRYING

Calamine Topical Suspension USP

POISON IVY, OAK, AND SUMAC DRYING LOTION

  • Skin Protectant
  • Shake Well Before Using

6 FL OZ (177 mL)

NDC 55319-063-30

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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