FAQ
What Testing Does BabyDance undergo to fulfill the FDA Requirements for Fertility Lubricants
The US FDA has a special category of medical devices, known as the PEB category, for lubricants designed to be used by couples who are trying to get pregnant. These PEB category lubricants, such as BabyDance, are tested extensively prior to FDA clearance to ensure that they are safe for sperm, eggs and embryos. And, once these products are on the market, manufacturers of these FDA-cleared fertility-friendly lubricants are required to confirm that each batch of product does not harm sperm or egg function.
FDA cleared fertility lubricants are specifically tested to ensure that the lubricant:
- is pH neutral (pH 7) and isosmotic/isotonic (e.g. 300 mOsmo/kg) with fertile cervical mucus and semen to prevent shock and damage to sperm and eggs.
- won't interfere with human sperm motility, survival, or integrity.
- is the correct viscosity to allow sperm to swim into and through the lubricant.
- won't interfere with embryo development.
- is safe to use for in vitro fertilization and other fertility interventions.
- is screened, both at time of production and throughout the shelf life of the lubricant, for endotoxins, which are toxins produced by bacteria that can harm sperm and egg function even at relatively low levels
When you are trying to conceive, the only sure way to know that your lubricant won't harm sperm is to choose an FDA-cleared fertility lubricant like BabyDance. We all know that reading labels and marketing information is confusing, so use this guide to avoid common mistakes when selecting a fertility-friendly lubricant:
1) Avoid lubricants with very low pH levels (~pH 3), very high osmolality (>3,000 mOsm/kg), and/or the products that contain small penetrating chemicals (for example,.glycerol)
2) Avoid confusing a lubricant labeled as non-spermicidal with an FDA-cleared fertility lubricant
3) Avoid lubricants that are labeled as organic or natural but are not FDA-cleared as fertility lubricants, as only the FDA-cleared lubricants are required to undergo testing that shows the product won't harm sperm or eggs
4) Avoid using household oils, as household oils often contain toxic peroxides and inflammatory chemicals that develop over time due to exposure to light, room temperature, and the purity of the oil.
Bottom line, identifying that a lubricant is FDA cleared for fertility (PEB category) is a sure way to know if that lubricant is safe to use when you are trying to conceive.
Does BabyDance Contain Added Artificial Fragrance
BabyDance does not contain any added fragrance, although you might notice that the lubricant has a mild floral scent. Unlike other fertility lubricants that use harsh parabens as preserving agents, BabyDance includes a bio-identical compound found in roses as a natural preservative, which gives BabyDance a light scent of roses.
What to Expect When Using BabyDance
BabyDance is pH-matched to your fertile quality cervical fluid and to your partner's semen, both of which have a pH of approximately 7. Throughout most of your cycle, your vaginal pH is typically much lower than that - somewhere between about 4 and 5. But, during your fertile window, it's important for your pH to rise to create a more friendly environment for sperm. When using BabyDance for the first time during their fertile window, most women don't notice any unusual sensations. However, some women feel a warming sensation when first using BabyDance. This sensation is more likely to occur in women with poor quality cervical mucus or hormonal imbalances, or in those women whose vaginal tissues are easily irritated by semen during intercourse. In other words, if your pH has not naturally risen on its own during your fertile period, you might feel a warming sensation when applying BabyDance with a pH of 7. Most women find that this warming sensation decreases with subsequent uses of BabyDance, as the pH of their vaginal tissues become balanced to the higher pH required for conception. If you continue to experience irritation after using BabyDance, please discontinue use and refer to the product labeling for more information.
What are the Ingredients in BabyDance
- Purifed water: BabyDance is a water-based lubricant, and contains neither oils nor silcone
- Cetyl hydroxyethylcellulose: This ingredient is a polymer derived from cellulose (a naturally occurring component found in the cell walls of plants), which is included in BabyDance to provide thickening and maintain the proper viscosity
- Hypromellose: This ingredient is a semisynthetic polymer most well-known for its use in eye drops (artificial tears)
- Carbomer h-polymer type B: This ingredient is a thickening agent used in many types of cosmetics. It gives BabyDance its desired viscosity.
- Sodium and potassium phosphate: These ingredients are part of the pH buffering system that keeps BabyDance in the proper pH range (about 7)
- Sodium chloride: This is salt – just like the salt you use on your food. It is included in BabyDance to ensure BabyDance is isotonic
- Raspberry-derived xylose: This ingredient is a sugar that provides a building block for the formation of protective natural mucus and energy for healthy bacterial function
- Sodium hydroxide: This ingredient is a pH adjusting agent, included to be sure that BabyDance stays in the proper pH range (about 7)
- Phenethyl alcohol: This ingredient is a naturally occurring substance found in roses that helps preserve BabyDance
- Caprylyl glycol: This is a hydrating compound derived from caprylic acid (which is a a fatty acid found in palm and coconut oils). This ingredient has antimicrobial activity and is used to naturally preserve products, so that harsh chemicals like parabens can be avoided
- Salvia sclarea: Commonly known as Clary Sage, this ingredient is a botanical with natural antibacterial activity, which helps to preserve BabyDance without the need for parabens
