Balmex®

Balmex®
SPL v1
SPL
SPL Set ID 9443a987-c7b2-4b0d-a9dc-02233135af81
Route
TOPICAL
Published
Effective Date 2018-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.113 g)
Inactive Ingredients
Mineral Oil Water Yellow Wax Microcrystalline Wax Sorbitan Sesquioleate Oenothera Biennis Olea Europaea Leaf Dimethicone 100 Tocopherol Methylparaben Soybean Oil Propylparaben Dexpanthenol Sarcosine Benzoic Acid Potassium Aspartate Potassium Hydroxide Magnesium Aspartate Anhydrous Sodium Cocoyl Glycinate Propylene Glycol White Wax

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-27

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • helps relieve and prevent rashes and irritation due to wetness from incontinence
  • protects chafed skin due to irritation and helps seal out wetness
When
  • avoid contact with eyes
Section 42229-5

Drug Facts

Section 51727-6

Inactive ingredients  mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021) 

Section 53413-1

For more information please visit 

www.BalmexAdult.com

Section 55105-1
Active Ingredients                                     Purpose
Zinc Oxide 11.3% Skin protectant
Warnings

For external use only

Directions
  • gently cleanse affected skin
  • pat dry with a clean, soft cloth or allow to air dry
  • apply generously to affected area as needed, especially after incontinence episodes
  • using a dry tissue to remove excess product from skin is most effective
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist 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 immediately.

Principal Display Panel 85 G Tube Carton

Activ

Guard™

NEUTRALIZES

IRRITANTS

Balmex®

ADULTCARE

RASH CREAM

ZINC OXIDE 11.3%

Soothes &

Protects Skin

From Irritation, Chafing & Rash

Dermatologist Tested

Works in One Use*

Odor-Free

NET WT 3 OZ (85 g)


Structured Label Content

Uses
  • helps relieve and prevent rashes and irritation due to wetness from incontinence
  • protects chafed skin due to irritation and helps seal out wetness
When
  • avoid contact with eyes
Section 42229-5 (42229-5)

Drug Facts

Section 51727-6 (51727-6)

Inactive ingredients  mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021) 

Section 53413-1 (53413-1)

For more information please visit 

www.BalmexAdult.com

Section 55105-1 (55105-1)
Active Ingredients                                     Purpose
Zinc Oxide 11.3% Skin protectant
Warnings

For external use only

Directions
  • gently cleanse affected skin
  • pat dry with a clean, soft cloth or allow to air dry
  • apply generously to affected area as needed, especially after incontinence episodes
  • using a dry tissue to remove excess product from skin is most effective
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist 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 immediately.

Principal Display Panel 85 G Tube Carton (PRINCIPAL DISPLAY PANEL - 85 g Tube Carton)

Activ

Guard™

NEUTRALIZES

IRRITANTS

Balmex®

ADULTCARE

RASH CREAM

ZINC OXIDE 11.3%

Soothes &

Protects Skin

From Irritation, Chafing & Rash

Dermatologist Tested

Works in One Use*

Odor-Free

NET WT 3 OZ (85 g)


Advanced Ingredient Data


Raw Label Data

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